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18,800 catalysts · 4,728 grant · 3,350 8k filing · 2,667 approval · 2,309 device 510k · 1,852 device recall · 1,612 device pma
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18,800 catalysts · 4,728 grant · 3,350 8k filing · 2,667 approval · 2,309 device 510k · 1,852 device recall · 1,612 device pma
Medical convenience kits UDPG88W PICC G-TUBE PACK-230209 — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573) — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
XERF EFFECTOR 60. Electrosurgical unit. — Reason: Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients. — Status: Ongoing
Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA T & A PACK FHHY25P HYSTEROSCOPY PACK HGML99G MAJOR LAP PACK HGXR41H X-RAY PACK HISU54M SET-UP PACK IHAA19AP PK A A A IHMP89K MINOR PROCEDURE PACK IHPD14AM PK PEDIATRIC LKVG10O VAG DELIVERY LMAG20G VASCULAR PACK LMLE46AA EXTREMITY LOWER PK MIEN58A DTC GENERAL ENDOSCOPY PACK(PS 209468) NUMB04H MAJOR BASIN SET 314666 OWBS11U BASIN SET - 206021 RCMS71B MIS SPECIALTY RCH SFMB55X MINOR BASIN - 208293 STBA09F BASIN SET TNBS21O BASIN SET 612833 UDBH37AX BASIC HEART PACK - 206044 UDMA50X MINOR ADULT - 206067 UICR54W ACS CRS PACK (PS055042) UIPC89D PROCUREMENT PACK UIPT13F PITCHER (PS 907953) UISB96AB SMALL BACK TABLE SETUP (PS 907419) — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209533 UICD62AN CARDIOVASCUALR SUPPLY (PS 907285) UICT16F CARDIO THORACIC DRAPE PACK (PS 907284) UIVA75I VASCULAR PACK — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40 — Reason: Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob. The stent is used with a primary distal embolic protection device. — Status: Ongoing
Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 SFLM54AB LAMINECTOMY PACK - 219659 UDLM94AA LAMINECTOMY PACK - 206064 UILM77AU LAMINECTOMY (PS 039500) UINR44P NEURO IR PERIPHERAL (PS 64405) UISH15AV SHUNT PACK (PS 039360) — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951 — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634) — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Product code: MNR. Advisory committee: Anesthesiology. Type: Traditional
Product code: FED. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KGI. Advisory committee: Radiology. Type: Traditional
Product code: QYT. Advisory committee: Microbiology. Type: Traditional
Product code: DXT. Advisory committee: Cardiovascular. Type: Traditional
Product code: MJN. Advisory committee: Cardiovascular. Type: Traditional
Product code: HAW. Advisory committee: Neurology. Type: Traditional
Product code: LJT. Advisory committee: General Hospital. Type: Special
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Special
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PQP. Advisory committee: PA. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: PNJ. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: SFA. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: Special (Immediate Track). Product code: NPV. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: NQA. Advisory committee: DE. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: SFA. Advisory committee: OR. Decision: APPR
Supplement type: Special (Immediate Track). Product code: LYJ. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30
Philips S5-2 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2 — Reason: Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data. — Status: Ongoing
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube — Reason: GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120. — Status: Ongoing
Philips S4-1 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component — Reason: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. — Status: Ongoing
Philips X3-1 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
Philips OMNI II TEE Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing