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2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 8k filing · 2,000 device pma
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2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 8k filing · 2,000 device pma
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MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; 4) C-SECTION PACK, REF DYNJ02577D; 5) C-SECTION PACK-LF, REF DYNJ0536924U; 6) C-SECTION PACK-LF, REF DYNJ0551169V; 7) C-SECTION PACK-LF, REF DYNJ0551409P; 8) C-SECTION PACK-LF, REF DYNJ07836R; 9) C-SECTION, REF DYNJ14103C; 10) C-SECTION PACK, REF DYNJ19417R; 11) C-SECTION PACK-LF, REF DYNJ33059B; 12) C-SECTION PACK SC-LF, REF DYNJ38063D; 13) C-SECTION PACK SC-LF, REF DYNJ38700G; 14) C-SECTION PACK-LF, REF DYNJ38845D; 15) C-SECTION PACK-LF, REF DYNJ38845F; 16) C-SECTION PACK, REF DYNJ44679L; 17) C-SECTION DELIVERY PACK-LF, REF DYNJ47808F; 18) C SECTION PACK, REF DYNJ48087I; 19) C-SECTION I, REF DYNJ51354B; 20) C-SECTION SAFETY PACK, REF DYNJ52481B; 21) C-SECTION SMMC, REF DYNJ59457B; 22) C-SECTION PACK, REF DYNJ59825A; 23) PK CUST C-SECTION ST MICH, REF DYNJ60544C; 24) C SECTION PACK, REF DYNJ64377D; 25) C-SECTION PACK, REF DYNJ64505B; 26) C SECTION SHARED, REF DYNJ64775C; 27) LDRP-C SECTION PACK-LF, REF DYNJ64834A; 28) LDRP-C SECTION PACK-LF, REF DYNJ64834B; 29) C-SECTION PACK-LF, REF DYNJ65031D; 30) C SECTION PK, REF DYNJ65403A; 31) C SECTION PACK-LF, REF DYNJ65765A; 32) C-SECTION PACK-LF, REF DYNJ69445; 33) C-SECTION PACK-LF, REF DYNJ69445A; 34) C SECTION DELIVERY PACK, REF DYNJ81604A; 35) C SECTION DELIVERY PACK, REF DYNJ81604B; 36) C SECTION PACK, REF DYNJ82949; 37) C-SECTION ADD ON PACK, REF DYNJ83507; 38) C-SECTION PACK, REF DYNJ83980; 39) C SECTION ACCESS, REF DYNJ85612; 40) ISSAQUAH C-SECTION PACK-LF, REF DYNJ85770; 41) C-SECTION PACK, REF DYNJ86173; 42) C-SECTION, REF DYNJ900266F; 43) C-SECTION, REF DYNJ903865D; 44) C-SECTION, REF DYNJ904612G; 45) C-SECTION, REF DYNJ904612I; 46) C-SECTION, REF DYNJ904653G; 47) C-SECTION, REF DYNJ904697F; 48) CDS C-SECTION CH, REF DYNJ906263D; 49) C SECTION, REF DYNJ908327; 50) C-SECTION -LF, REF DYNJ9932207R; 51) C-SECTION -LF, REF DYNJ9932207S; 52) C-SECTION PACK, REF DYNJV0322A; 53) GP-C SECTION PACK-LF, REF PHS396980007C. — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. — Status: Ongoing
MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. — Status: Ongoing
Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00 — Reason: Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. — Status: Ongoing
Material Processing Laser Products — Reason: Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3) — Status: Ongoing
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A — Reason: The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors. — Status: Ongoing
MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. — Status: Ongoing
MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS860015X; 3) MINOR LAPAROTOMY CDS, REF CDS860016R; 4) MINOR LAPAROTOMY CDS, REF CDS860016S; 5) LAPAROTOMY CDS #31-RF, REF CDS860062S; 6) LAPAROSCOPY CDS, REF CDS860194I; 7) BASIC LAPAROSCOPY CDS, REF CDS920080T; 8) GENERAL LAPAROSCOPY, REF CDS930027V; 9) GENERAL LAPAROSCOPY, REF CDS930027X; 10) GENERAL MINOR CDS, REF CDS980246V; 11) BASIC CDS, REF CDS982936V; 12) MAJOR ABDOMINAL CDS, REF CDS983759L; 13) GENERAL SURGERY CDS, REF CDS983914L; 14) GENERAL LAP, REF CDS984251N; 15) ACH MINOR PROCEDURE, REF CDS985451G; 16) SCOPE LAP THOR PACK, REF DYNJ00210N; 17) MAJOR LAPAROTOMY PACK, REF DYNJ00387P; 18) MAJOR ABDOMINAL HARPER PACK-LF, REF DYNJ0160657D; 19) LAPAROTOMY PACK-LF, REF DYNJ0161299C; 20) LAPAROTOMY PACK-LF, REF DYNJ0311538N; 21) MAJOR PACK-LF, REF DYNJ0386381L; 22) DONOR FREE FLAP PACK-LF, REF DYNJ0426069N; 23) LAPAROTOMY PACK-LF, REF DYNJ0519288N; 24) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401S; 25) MAJOR LAPAROTOMY PACK, REF DYNJ20819M; 26) MAJOR ABDOMINAL, REF DYNJ23429G; 27) MINI LAPAROTOMY #16-RF, REF DYNJ27322S; 28) MINI LAPAROTOMY #16-RF, REF DYNJ27322T; 29) TN LAPAROTOMY PACK-LF, REF DYNJ34206I; 30) LAPAROTOMY, REF DYNJ34424N; 31) COREWELL TSC- LAP PACK-LF, REF DYNJ37100I; 32) GENERAL LAP PACK, REF DYNJ38223C; 33) LAP CHOLE PACK, REF DYNJ38228C; 34) MINOR PACK, REF DYNJ41418I; 35) GENERAL PACK-LF, REF DYNJ43213J; 36) HERNIA PACK, REF DYNJ44683L; 37) GENERAL ABDOMINAL, REF DYNJ44870J; 38) LAP CHOLE PACK, REF DYNJ44873I; 39) LAP RENAL PACK, REF DYNJ44875O; 40) MAJOR LAPAROTOMY, REF DYNJ45334G; 41) MAJOR LAPAROTOMY, REF DYNJ45334J; 42) MINOR PROCEDURE, REF DYNJ45336J; 43) MINOR PROCEDURE PACK, REF DYNJ47057D; 44) MINOR PROCEDURE PACK, REF DYNJ47057F; 45) MAJOR BASIC PACK (MBGSE)227-LF, REF DYNJ47696J; 46) LAP CHOLE PACK, REF DYNJ48092G; 47) LAPAROTOMY PACK, REF DYNJ48093F; 48) ISS GENERAL PACK, REF DYNJ48921I; 49) MINOR UROLOGY PACK, REF DYNJ49310F; 50) HERNIA SGM PACK-LF, REF DYNJ51434B; 51) MINOR GENERAL PACK, REF DYNJ52329C; 52) MINOR GENERAL PACK, REF DYNJ52329D; 53) MINOR GENERAL PACK, REF DYNJ52329F; 54) MINOR LAPAROTOMY PACK-LF, REF DYNJ52863D; 55) MINOR GENERAL PACK, REF DYNJ53036G; 56) MINOR GENERAL PACK, REF DYNJ53036I; 57) IPP PENILE PROSTHESIS PACK, REF DYNJ58061J; 58) MAJOR LAPAROTOMY PACK, REF DYNJ58561D; 59) MAJOR LAPAROTOMY PACK, REF DYNJ58561F; 60) MINOR PACK, REF DYNJ58562D; 61) MINOR PACK, REF DYNJ58562F; 62) MINOR GENERAL PACK, REF DYNJ59358D; 63) PACK HERNIA INGUINAL, REF DYNJ60145B; 64) PK CUST MAJOR ST MICHAEL, REF DYNJ60782B; 65) CENTRACARE PLAZA-LAP CHOLE PK, REF DYNJ61620C; 66) MINOR GEN PACK, REF DYNJ61661A; 67) SLCH MAJOR GENERAL PACK, REF DYNJ61666A; 68) DAVINCI PROSTATE PACK, REF DYNJ61711B; 69) THORACIC PACK, REF DYNJ62015C; etc — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. — Status: Ongoing
MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF, REF DYNJ0161262C; 7) VASCULAR PACK-LF, REF DYNJ0421380P; 8) GEN FEM POP #14-RF, REF DYNJ21877W; 9) VASCULAR PACK, REF DYNJ22350L; 10) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC; 11) OPEN HEART PACK, REF DYNJ37284K; 12) ACH CABG ADD-ON, REF DYNJ38175L; 13) CARDIOVASCULAR PACK, REF DYNJ42921G; 14) CABG PACK-LF, REF DYNJ43207K; 15) HEART DRAPING PACK-LF, REF DYNJ43214F; 16) AAA PACK, REF DYNJ44847I; 17) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U; 18) FISTULA PACK, REF DYNJ44869K; 19) MAJOR VASCULAR LEG-TEAM, REF DYNJ44879K; 20) PERMANENT PACING, REF DYNJ44886M; 21) CAROTID VASCULAR ENDARTERECTMY, REF DYNJ50528M; 22) DR DANIELSON AC PACK, REF DYNJ51038R; 23) VASCULAR CAROTID PACK, REF DYNJ56838F; 24) VASCULAR FEM PACK, REF DYNJ56839D; 25) PK CUST OPEN HEART A AND B, REF DYNJ60548B; 26) PK CUST CAROTID ST MICHAE, REF DYNJ60783B; 27) CAROTID PACK, REF DYNJ61659A; 28) VASCULAR MINOR PACK, REF DYNJ62097C; 29) VASCULAR PACK-LF, REF DYNJ65039C; 30) PACEMAKER PACK, REF DYNJ66033B; 31) DR MELLINGER AC PACK, REF DYNJ80609D; 32) HEART PACK II, REF DYNJ81581B; 33) AV FISTULA PACK, REF DYNJ81605; 34) MAJOR VASCULAR PACK, REF DYNJ81610B; 35) CABG ACCESSORY PACK, REF DYNJ82166; 36) VALVE ACCESSORY PACK, REF DYNJ82217; 37) PERIVASCULAR CUSTOM PACK, REF DYNJ84017B; 38) CAROTID ENDARTERECTOMY PACK-LF, REF DYNJ85109; 39) ACH OPEN HEART A&B PK, REF DYNJ85110; 40) VASCULAR ABDOMINAL PACK, REF DYNJ85118; 41) AV FISTULA PACK-LF, REF DYNJ85121; 42) CARDIAC - DEEIK PACK, REF DYNJ85637; 43) VASCULAR, REF DYNJ900293K; 44) VASCULAR-LF, REF DYNJ900714C; 45) HEART/MAJOR VASCULAR, REF DYNJ901066K; 46) MODULE OPEN HEART, REF DYNJ903042P; 47) VASCULAR/OR ANGIO, REF DYNJ905079F; 48) OPEN HEART, REF DYNJ905497B; 49) AAA, REF DYNJ906175B; 50) VASCULAR ABDOMINAL, REF DYNJ907105D; 51) CV COMPLETE, REF DYNJ907904A; 52) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820; 53) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820A. — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. — Status: Ongoing
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA — Reason: There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing
MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK CDS, REF CDS780148R; 4) NEURO-LAMI CDS, REF CDS780208I; 5) TOTAL HIP, REF CDS920027Y; 6) TOTAL KNEE, REF CDS940072Y; 7) TOTAL KNEE REPLACEMENT CDS, REF CDS940823AB; 8) TOTAL HIP CDS, REF CDS940843AA; 9) TOTAL HIP CDS, REF CDS940963Y; 10) SHOULDER CDS, REF CDS941065L; 11) LAMINECTOMY CDS-LF, REF CDS981923X; 12) TOTAL KNEE CDS, REF CDS982823S; 13) LOWER EXTREMITY CDS, REF CDS982943S; 14) LOWER EXTREMITY CDS, REF CDS982943T; 15) TOTAL KNEE, REF CDS982986U; 16) EXTREMITY CDS, REF CDS983031Q; 17) PODIATRY CDS, REF CDS983610L; 18) TOTAL HIP CDS-LF, REF CDS983761N; 19) BASIC ORTHO CDS, REF CDS983769L; 20) UPPER EXTREMITY CDS, REF CDS983907L; 21) LOWER EXTREMITY CDS, REF CDS983909P; 22) GENERAL ORTHO CDS, REF CDS983915M; 23) MAJOR ORTHO, REF CDS984253L; 24) LOWER EXTREMTIY, REF CDS984254M; 25) TOTAL KNEE, REF CDS985566R; 26) ORTHO PACK, REF DYNJ00284M; 27) CRANIOTOMY PACK-LF, REF DYNJ0160354C; 28) CRANIOTOMY PACK-LF, REF DYNJ0161342C; 29) CRANIOTOMY PACK-LF, REF DYNJ0161342D; 30) CRANIOTOMY HARPER PACK-LF, REF DYNJ0162022G; 31) SPINE PACK-LF, REF DYNJ0376635P; 32) GP-TOTAL JOINT -LF, REF DYNJ0396868V; 33) GP-EXTREMITY/SHOULDER PACK-LF, REF DYNJ0396906P; 34) EXTREMITY PACK-LF, REF DYNJ0519273N; 35) TOTAL KNEE PACK-LF, REF DYNJ0530895AO; 36) TOTAL KNEE PACK-LF, REF DYNJ0530895AP; 37) UPPER EXTREMITY PACK-LF, REF DYNJ0532846S; 38) LOWER EXTREMITY PACK-LF, REF DYNJ0532852Q; 39) ACL SSC PACK-LF, REF DYNJ0536892U; 40) TOTAL HIP PACK-LF, REF DYNJ0536903AL; 41) TOTAL HIP PACK-LF, REF DYNJ0536903AM; 42) LOWER EXTREMITY PACK-LF, REF DYNJ0587115R; 43) TOTAL HIP PACK-LF, REF DYNJ0618354V; 44) TOTAL KNEE PACK-LF, REF DYNJ0646272S; 45) SPINE ANT POST ADD A PACK-LF, REF DYNJ0753208J; 46) OPEN SHOULDER SSC PACK, REF DYNJ0840659T; 47) TOTAL JOINT PACK-LF, REF DYNJ0885263F; 48) TOTAL KNEE PACK, REF DYNJ21813J; 49) CRANIO/MAXILOFACIAL #49-RF, REF DYNJ21826R; 50) TOTAL HIP PACK, REF DYNJ27315K; 51) PODIATRY PACK, REF DYNJ33978K; 52) LOWER EXTREMITY, REF DYNJ34420N; 53) LOWER EXTREMITY, REF DYNJ34420O; 54) GENERAL ORTHO, REF DYNJ34428O; 55) ARTHROSCOPY PACK, REF DYNJ35835G; 56) HAND PACK, REF DYNJ37697J; 57) ACH SPINE PACK, REF DYNJ38042K; 58) SHOULDER ARTHROSCOPY PACK, REF DYNJ38224C; 59) LAMINECTOMY PACK, REF DYNJ38227C; 60) EXTREMITY PACK, REF DYNJ38234G; 61) TOTAL JOINT PACK, REF DYNJ40982D; 62) SPINE PACK, REF DYNJ40995B; 63) EXTREMITY PACK, REF DYNJ41416G; 64) TOTAL JOINT PACK, REF DYNJ42793D; 65) CRANIOTOMY PACK-LF, REF DYNJ43208G; 66) HIP I PACK-LF, REF DYNJ43215I; 67) LAMINECTOMY PACK-LF, REF DYNJ43218G; 68) LIMB PACK-LF, REF DYNJ43220G; 69) SPLIT PACK-LF, REF DYNJ43225G; 70) TOTAL KNEE PACK-LF, REF DYNJ43226I; 71) EXTREMITY PACK, REF DYNJ44681J; 72) SHOULDER PACK, REF DYNJ44685L; 73) TOTAL KNEE PACK, REF DYNJ44687L; 74) UPPER EXTREMITY PACK, REF DYNJ44688I; 75) PODIATRY PACK, REF DYNJ44692G; 76) ACL PACK, REF DYNJ44849F; 77) CENTRACARE PLAZA-MINOR ORTHO, REF DYNJ44860I; 78) MAJOR EXTREMITY, REF DYNJ44878D; 79) ORTHO HIP, REF DYNJ44884G; 80) EXTREMITY PACK, REF DYNJ45332G; — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. — Status: Ongoing
MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; 3) BASIC GENERAL CDS, REF CDS980566F; 4) TOTAL KNEE CDS, REF CDS982823R; 5) BASIC CDS, REF CDS982936U; 6) UPPER EXTREMITY CDS, REF CDS983907M; 7) MAJOR ABDOMINAL CDS, REF CDS983908Q; 8) LOWER EXTREMITY CDS, REF CDS983909Q; 9) GENERAL SURGERY CDS, REF CDS983914M; 10) GENERAL ORTHO CDS, REF CDS983915N; 11) GENERAL LAP, REF CDS984251O; 12) ROBOTIC, REF CDS984262O; 13) HYPOSPADIUS PACK, REF DYNJ00282Q; 14) MINOR HARPER PACK-LF, REF DYNJ0161694F; 15) THROMBECTOMY HARPER PACK-LF, REF DYNJ0161832F; 16) MAJOR COMPONENT HARPER PACK-LF, REF DYNJ0161949C; 17) MINOR PACK-LF, REF DYNJ0259893T; 18) TOTAL KNEE PACK LF, REF DYNJ0368519AA; 19) TOTAL KNEE PACK LF, REF DYNJ0368519Y; 20) PEDIATRIC BASIC PACK-LF, REF DYNJ0406353N; 21) DONOR FREE FLAP PACK-LF, REF DYNJ0426069O; 22) DONOR FREE FLAP PACK-LF, REF DYNJ0426069P; 23) VASCULAR PACK-LF, REF DYNJ0429345R; 24) GENERAL PACK-LF, REF DYNJ0506906S; 25) BASIC PACK-LF, REF DYNJ0519294K; 26) TOTAL HIP PACK-LF, REF DYNJ0537284AC; 27) TOTAL HIP PACK-LF, REF DYNJ0537284AD; 28) BASIC MAJOR PACK-LF, REF DYNJ0537337AA; 29) BASIC MAJOR PACK-LF, REF DYNJ0537337Y; 30) BASIC GENERAL PACK-LF, REF DYNJ14004N; 31) MVFF/FIBU #54-RF, REF DYNJ21927S; 32) AUGMENTATION #87-RF, REF DYNJ27319W; 33) BASIC SET-UP, REF DYNJ34979B; 34) BASIC PACK, REF DYNJ35834D; 35) MINOR SINGLE BASIN PACK, REF DYNJ37698M; 36) ISSAQUAH PEDIATRIC PACK, REF DYNJ39001F; 37) TOTAL JOINT PACK, REF DYNJ40982F; 38) BASIC PACK, REF DYNJ42791F; 39) TOTAL JOINT PACK, REF DYNJ42793F; 40) RRP PACK, REF DYNJ44109F; 41) CENTRACARE BASIC PACK, REF DYNJ44858J; 42) DONOR PACK, REF DYNJ44865G; 43) UROLOGY RECONSTRUCTION PACK, REF DYNJ44866P; 44) UROLOGY PACK, REF DYNJ44899R; 45) ENDOCRINE PACK-RF, REF DYNJ47131F; 46) ENDOCRINE PACK-RF, REF DYNJ47131G; 47) ORTHO MAJOR, REF DYNJ48131K; 48) ENDO BLADDER PACK, REF DYNJ49672M; 49) ORTHO SPINE SUPPLEMENT PACK-LF, REF DYNJ51445B; 50) MINOR GENERAL PACK, REF DYNJ53036J; 51) ACL PACK, REF DYNJ54634I; 52) READY SET CLOSE PACK, REF DYNJ57214C; 53) KIDNEY TRANSPLANT, REF DYNJ57455C; 54) TOTAL HIP PACK, REF DYNJ58563F; 55) TOTAL HIP PACK, REF DYNJ58563G; 56) TOTAL KNEE PACK, REF DYNJ58564F; 57) TRANSPLANT PACK, REF DYNJ59201D; 58) PACK RECTAL, REF DYNJ60156C; 59) C-SECTION PK CABRINI, REF DYNJ60577B; 60) MINI KIT PACK CABRINI, REF DYNJ60579B; 61) MAJOR GENERAL CHRISTUS, REF DYNJ61184D; 62) PK CUST BASIC PK CHRISTUS, REF DYNJ61647B; 63) THORACIC PACK, REF DYNJ62015B; 64) MAJOR GENERAL PACK, REF DYNJ62397B; 65) VASCULAR PACK, REF DYNJ62683D; 66) GENDER AFFIRMING SURGERY, REF DYNJ66252C; 67) GENDER AFFIRMING SURGERY, REF — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. — Status: Ongoing
Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell¿ Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments. — Reason: Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound — Status: Ongoing
MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2) BASIN PACK, REF DYNJ50123D; 3) MAJOR BASIN PACK, REF DYNJ59816A; 4) OSC BASIN PACK, REF DYNJ68217A. — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. — Status: Ongoing
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY, REF DYNJ908839A. — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. — Status: Ongoing
IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra — Reason: There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597 — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. — Status: Ongoing
MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O; 3) MINOR VAGINAL #76-RF, REF DYNJ27434R; 4) ABDOMINAL HYST PACK, REF DYNJ44848M; 5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 6) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P; 7) URO GYN, REF DYNJ50047G; 8) ISS VAG HYST PACK, REF DYNJ50315F; 9) PK MAJOR GYN ST MICHAEL C, REF DYNJ60554B; 10) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B; 11) LAVH, REF DYNJ900298L; 12) LITHOTOMY-LF, REF DYNJ900721C; 13) GP-T A H PACK-LF, REF PHS396954006G; 14) GP-VAG HYSTERECTOMY PACK-LF, REF PHS396975006F. — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. — Status: Ongoing
MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F; 6) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O; 7) MAJOR ENT MB PACK-LF, REF DYNJ0429404P; 8) THYROID MOFF PACK-LF, REF DYNJ0429430S; 9) NASALPLASTY #61-RF, REF DYNJ27320V; 10) MIDDLE EAR PACK, REF DYNJ55235C; 11) HEAD AND NECK, REF DYNJ64235B; 12) NECK PACK SRM-LF, REF DYNJ65020C; 13) ACH HEAD & NECK PACK-LF, REF DYNJ67754B; 14) ENT HEAD NECK PACK, REF DYNJ68211B; 15) OSC ENT HEAD PACK, REF DYNJ68957B; 16) EAR UM-LF, REF DYNJ902331D; 17) HEAD&NECK, REF DYNJ906655G; 18) ENT-LF, REF DYNJ907577; 19) MAJOR HEAD AND NECK PPS, REF DYNJ9425991Q; 20) MINOR ENT # 56653-LF, REF DYNJVB91072A. — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. — Status: Ongoing
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO PACK-LF, REF DYNJ0038440C; 4) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 5) NEURO-ORTHO EXTRAS, REF DYNJ44882M; 6) LAMINECTOMY, REF DYNJ903870F. — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. — Status: Ongoing
All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00 — Reason: Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. — Status: Ongoing
Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 138919-01 138920-01 138921-01 138922-01 138923-01 138924-01 138926-01 138927-01 138928-01 138929-01 138930-01 138931-01 138932-01 138933-01 138934-01 138936-01 138937-01 138938-01 138939-01 138940-01 138941-01 138942-01 138943-01 138944-01 138945-01 138946-01 138947-01 138948-01 138949-01 138950-01 138951-01 138952-01 138953-01 138954-01 138955-01 138956-01 138957-01 138958-01 138959-01 138960-01 138961-01 138962-01 138963-01 138964-01 138965-01 138966-01 138967-01 138968-01 138969-01 138970-01 138971-01 138972-01 138973-01 138974-01 138975-01 138976-01 138977-01 138978-01 138989-01 138990-01 139000-01 139001-01 139002-01 139011-01 139013-01 139016-01 139018-01 139019-01 139020-01 139021-01 139022-01 139023-01 139028-01 139062-01 139063-01 139073-01 139082-01 139084-01 139085-01 139086-01 139091-01 139122-01 139125-01 139126-01 139127-01 139128-01 139131-01 139141-01 139142-01 139156-01 139163-01 139170-01 139171-01 139172-01 139174-01 139175-01 155081-01 155082-01 155083-01 155084-01 155085-01 155086-01 155087-01 155088-01 155089-01 155090-01 155091-01 155092-01 155093-01 155094-01 155095-01 155096-01 155097-01 155098-01 155099-01 155100-01 155101-01 155102-01 155103-01 155104-01 155105-01 155106-01 155107-01 155108-01 155109-01 155110-01 155111-01 155112-01 155113-01 155114-01 155115-01 155116-01 155117-01 155118-01 155119-01 155120-01 155121-01 155122-01 155123-01 155124-01 155125-01 155126-01 155127-01 155128-01 155129-01 155130-01 155131-01 155132-01 155133-01 155134-01 155135-01 155136-01 155137-01 155138-01 155139-01 155140-01 155141-01 155142-01 155143-01 155144-01 155145-01 155146-01 155147-01 155148-01 155149-01 155150-01 155151-01 155152-01 155153-01 155154-01 155155-01 155156-01 155157-01 155159-01 155160-01 155161-01 155163-01 155165-01 155166-01 155167-01 155168-01 155169-01 155171-01 155288-01 155293-01 155294-01 155299-01 155302-01 155303-01 155304-01 155305-01 155310-01 155311-01 169-03 169-04 169-05 169-06 169-07 169-08 169-09 169-10 169-100 169-101 169-102 169-103 169-104 169-105 169-106 169-107 169-108 169-109 169-11 169-110 169-111 169-112 169-113 169-114 169-115 169-12 169-120 169-124 169-125 169-127 169-128 169-129 169-13 169-131 169-132 169-137 169-138 169-139 169-14 169-140 169-141 169-142 169-143 169-144 169-145 169-15 169-150 169-151 169-152 169-155 169-156 169-159 169-16 169-160 169-161 169-162 169-163 169-164 169-18 169-19 169-20 169-21 169-22 169-23 169-24 169-25 169-26 169-27 169-28 169-29 169-30 169-31 169-32 169-33 169-34 169-35 169-36 169-37 169-38 169-39 169-40 169-41 169-42 169-43 169-44 169-45 169-46 169-47 169-48 169-49 169-50 169-51 169-52 169-53 169-54 169-55 169-56 169-57 169-58 169-59 169-60 169-61 169-62 169-63 169-64 169-65 169-66 169-67 169-68 169-69 169-70 169-71 169-72 169-73 169-74 169-75 169-76 169-77 169-78 169-79 169-80 169-81 169-82 169-83 169-84 169-85 169-86 169-87 169-88 169-89 169-90 169-91 169-92 169-93 169-94 169-95 169-96 169-97 169-98 169-99 — Reason: Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. — Status: Ongoing
Radiography 7300 C; Model Number: 712037; — Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues. — Status: Ongoing
Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing
Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator 18cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing
DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035; — Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues. — Status: Ongoing
Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. — Reason: Potential for contamination with cotton fibers. — Status: Ongoing
Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT10 Generator 18.8 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing
Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 44cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing
Precision CRF; Model Number: 706400; — Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues. — Status: Ongoing
Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10 Generator 44 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 7. Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L. 8. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 9. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L. 10. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 11. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 12. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 13. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 14. Impella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L. 15. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 16. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 17. Impella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L. 18. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 19. Impella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L. 20. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 21. Optical AIC w/Impella Connect,Pack'd, CA; Product Code: 0042-0040-CA. 22. AIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT. 23. AIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT-L. 24. Optical AIC w/Impella Connect,Pack'd, EU; Product Code: 0042-0040-EU. 25. Optical AIC w/Impella Connect,EU,Loaner; Product Code: 0042-0040-EU-L. 26. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP. 27. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L. 28. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 29. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. 30. Optical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L. 31. Dbl optical, AIC Impella Connect, Phg US; Product Code: 1000201. 32. AIC w/Impella Connect for ECP; Product Code: 1000432. — Reason: Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC). — Status: Ongoing
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer — Reason: An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results. — Status: Ongoing
Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing
Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgG antibodies against measles virus in a patient's serum or plasma Component: not a component — Reason: Due to distributing the measles IgG IVD without a premarket approved/cleared. — Status: Ongoing
ProxiDiagnost N90; Model Number: 706110; — Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues. — Status: Ongoing
Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing
CombiDiagnost R90; Model Number: 709031; — Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues. — Status: Ongoing
Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical Cutting And Coagulation Device — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing
Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible with FT10 Generator, FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing
Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control — Reason: The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays. — Status: Ongoing
Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w/FT10 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing
Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. — Reason: Potential for contamination with cotton fibers. — Status: Ongoing
Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer — Reason: An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results. — Status: Ongoing
MAGNETOM Cima.X Upgrade. Model Number: 11689304. — Reason: There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing
Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing
DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032; — Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues. — Status: Ongoing
CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X 11.5 CM/FCX100412, UNIFORM 5MM X 9.7 CM/FCX100509, UNIFORM 5MM X 17 CM/FCX100517, UNIFORM 6MM X 11.9 CM/FCX100611, UNIFORM 6MM X 26 CM/FCX100626, UNIFORM 7MM X 13.9 CM/FCX100713, UNIFORM 7MM X 30 CM/FCX100730, UNIFORM 8MM X 16.1 CM/FCX100816, UNIFORM 8MM X 29 CM/FCX100829, UNIFORM 3D 2MM X 2.5 CM/FCX140225, UNIFORM 3D 3MM X 3 CM/FCX140303, UNIFORM 3D 3MM X 4 CM/FCX140304, UNIFORM 3D 3MM X 6 CM/FCX140306, UNIFORM 3D 4MM X 6 CM/FCX140406, UNIFORM 3D 4MM X 8 CM/FCX140408, UNIFORM 3D 4MM X 4.5 CM/FCX140445, UNIFORM 3D 5MM X 7 CM/FCX140507, UNIFORM 3D 5MM X 12 CM/FCX140512, UNIFORM 3D 6MM X 9 CM/FCX140609, UNIFORM 3D 6MM X 15 CM/FCX140615, UNIFORM 3D 7MM X 11 CM/FCX140711, UNIFORM 3D 7MM X 17 CM/FCX140717, UNIFORM 3D 8MM X 12 CM/FCX140812, UNIFORM 3D 8MM X 20 CM/FCX140820, UNIFORM 3D 9MM X 14 CM/FCX140914, UNIFORM 3D 9MM X 22 CM/FCX140922, UNIFORM 3D 10MM X 16 CM/FCX141016, UNIFORM 3D 10MM X 25 CM/FCX141025, UNIFORM 3D 11MM X 18 CM/FCX141118, UNIFORM 3D 11MM X 27 CM/FCX141127, UNIFORM 3D 12MM X 19 CM/FCX141219, UNIFORM 3D 12MM X 30 CM/FCX141230, UNIFORM XL 5MM X 10 CM/FCX180510, UNIFORM XL 6MM X 12.2 CM/FCX180612, UNIFORM XL 7MM X 14.3 CM/FCX180714, UNIFORM XL 8MM X 13.6 CM/FCX180813, UNIFORM XL 8MM X 30 CM/FCX180830, UNIFORM XL 9MM X 15.3 CM/FCX180915, UNIFORM XL 9MM X 33 CM/FCX180933, UNIFORM XL 10MM X 17.1 CM/FCX181017, UNIFORM XL 10MM X 34 CM/FCX181034, UNIFORM XL 11MM X 18.9 CM/FCX181118, UNIFORM XL 11MM X 37 CM/FCX181137, UNIFORM XL 12MM X 20.7 CM/FCX181220, UNIFORM XL 12MM X 40 CM/FCX181240, UNIFORM XL 13MM X 43 CM/FCX181343, UNIFORM XL 14MM X 47 CM/FCX181447, UNIFORM XL 15MM X 50 CM/FCX181550, UNIFORM XL 16MM X 47 CM/FCX181647, UNIFORM XL 17MM X 50 CM/FCX181750, UNIFORM XL 18MM X 46 CM/FCX181846, UNIFORM XL 19MM X 50 CM/FCX181950, UNIFORM XL 20MM X 50 CM/FCX182050, FREEFORM MINI 1MM X 1CM/MCR091010, FREEFORM MINI 1MM X 1.5CM/MCR091015, FREEFORM MINI 1MM X 2CM/MCR091020, FREEFORM MINI 1MM X 2.5CM/MCR091025, FREEFORM MINI 1MM X 3CM/MCR091030, FREEFORM MINI 1MM X 4CM/MCR091040, FREEFORM MINI 1.5MM X 2CM/MCR091520, FREEFORM MINI 1.5MM X 2.5CM/MCR091525, FREEFORM MINI 1.5MM X 3CM/MCR091530, FREEFORM MINI 1.5MM X 4CM/MCR091540, FREEFORM MINI 2MM X 2CM/MCR092020, FREEFORM MINI 2MM X 3CM/MCR092030, FREEFORM MINI 2MM X 4CM/MCR092040, FREEFORM MINI 2MM X 6CM/MCR092060, FREEFORM MINI 2.5MM X 3.5CM/MCR092535, FREEFORM MINI 2.5MM X 4.5CM/MCR092545, FREEFORM MINI 2.5MM X 5.5CM/MCR092555, FREEFORM MINI 3MM X 4CM/MCR093040, FREEFORM MINI 3MM X 6CM/MCR093060, FREEFORM MINI 3MM X 8CM/MCR093080, FREEFORM 2MM X 2 CM/SCR120202, FREEFORM 3MM X 6 CM/SCR120306, FREEFORM 3MM X 8 CM/SCR120308, FREEFORM 4MM X 7 CM/SCR120407, FREEFORM 4MM X 10 CM/SCR120410, FREEFORM 4MM X 12 CM/SCR120412, FREEFORM 5MM X 10 CM/SCR120510, FREEFORM 5MM X 15 CM/SCR120515, FREEFORM 6MM X 10 CM/SCR120610, FREEFORM 6MM X 15 CM/SCR120615, FREEFORM 6MM X 20 CM/SCR120620, FREEFORM 7MM X 15 CM/SCR120715, FREEFORM 7MM X 21 CM/SCR120721, FREEFORM 8MM X 15 CM/SCR120815, FREEFORM 8MM X 24 CM/SCR120824, FREEFORM 9MM X 25 CM/SCR120925, FREEFORM 10MM X 30 CM/SCR121030, FREEFORM 12MM X 30 CM/SCR121230, FREEFORM 2.5MM X 5 CM/SCR122505, FREEFORM 2.5MM X 3.5 CM/SCR122535, FREEFORM 3.5MM X 9 CM/SCR123509, FREEFORM 3.5MM X 7.5 CM/SCR123575, HELIFORM SOFT 1.5MM X 4 CM/SHD100154, HELIFORM SOFT 2MM X 8 CM/SHD100208, HELIFORM SOFT 2.5MM X 10 CM/SHD100250, HELIFORM SOFT 2.5MM X 8 CM/SHD100258, HELIFORM SOFT 3MM X 8 CM/SHD100308, HELIFORM SOFT 3MM X 10 CM/SHD100310, HELIFORM SOFT 4MM X 8 CM/SHD100408, HELIFORM SOFT 4MM X 10 CM/ SHD100410, HELIFORM SOFT 5MM X 10 CM/ SHD100510, HELIFORM SOFT 5MM X 15 CM/ SHD100515, HELIFORM SOFT 6MM X 12 CM/ SHD100612, HELIFORM SOFT 6MM X 16 CM/ SHD100616, HELIFORM SOFT 7MM X 16 CM/ SHD100716, HELIFORM SOFT 7MM X 20 CM/ SHD100720, HELIFORM SOFT 8MM — Reason: Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention. — Status: Ongoing
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014 — Reason: IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body. — Status: Ongoing
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234; — Reason: The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model. — Status: Ongoing
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo — Reason: As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout. — Status: Ongoing