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Week of Dec 22, 2025

21

Dec 24, 2025device recall248d agoMedline Industries, LP device recall (Cls II)

Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit — Reason: A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea. — Status: Ongoing

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Dec 24, 2025device recall248d agoZimmer Surgical Inc device recall (Cls II)

Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version: Software version v2.06 or prior are within scope of the recall for A.T.S.¿ 3200TS Product Description: A.T.S 3200TS Tourniquet Systems Component: N/A — Reason: Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located. — Status: Ongoing

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Dec 24, 2025device recall248d agoMedline Industries, LP device recall (Cls II)

Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108 — Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. — Status: Ongoing

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Dec 24, 2025device recall248d agoGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING device recall (Cls II)

GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission — Reason: There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation). — Status: Ongoing

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Dec 24, 2025device recall248d agoZimmer Surgical Inc device recall (Cls II)

Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S.¿ 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A — Reason: Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located. — Status: Ongoing

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Dec 24, 2025device recall248d agoMedline Industries, LP device recall (Cls II)

Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A — Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. — Status: Ongoing

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Dec 24, 2025device recall248d agoMedline Industries, LP device recall (Cls II)

Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B — Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. — Status: Ongoing

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Dec 24, 2025device recall248d agoMedline Industries, LP device recall (Cls II)

Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESSING CHANGE K, Kit SKU DT19665; 6) NEONATAL DRESSING CHANGE KIT, Kit SKU DT21495; 7) NICU CVC DRESSING CHANGE TRAY, Kit SKU DT22510A; 8) DRESSING CHANGE TRAY W/TEG CHG, Kit SKU DYNDC3114B; 9) DRESSING CHANGE KIT, Kit SKU DYNDC3351. — Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. — Status: Ongoing

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Dec 24, 2025device recall248d agoMedline Industries, LP device recall (Cls II)

Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B — Reason: A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea. — Status: Ongoing

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Dec 24, 2025device recall248d agoMedline Industries, LP device recall (Cls II)

Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A — Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. — Status: Ongoing

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Dec 24, 2025device recall248d agoMedline Industries, LP device recall (Cls II)

Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING CHANGE W/ TEG CHG, Kit SKU DYNDC3222A; 7) PICC PROCEDURE PACK, Kit SKU DYNJ59067A; 8) PICC PROCEDURE PACK, Kit SKU PHS950205004B. — Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. — Status: Ongoing

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Dec 24, 2025device recall248d agoMedline Industries, LP device recall (Cls II)

1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit SKU DYNDC3107; 8) NON STERILE DIALYSIS KIT, Kit SKU DYNDH1029C; 9) UMBILICAL TRAY W/3.5&5FR CATH, Kit SKU UVT1250; 10) UMBILICAL VESSEL TRAY, Kit SKU UVT835; 11) HEMODIALYSIS TRAY, Kit SKU VAR101HVAA. — Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. — Status: Ongoing

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Dec 24, 2025device recall248d agoMedline Industries, LP device recall (Cls II)

Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088 — Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. — Status: Ongoing

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Dec 24, 2025device recall248d agoMedline Industries, LP device recall (Cls II)

Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109 — Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. — Status: Ongoing

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Dec 24, 2025device recall248d agoMedline Industries, LP device recall (Cls II)

Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B — Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. — Status: Ongoing

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Dec 26, 2025device recall246d agoCardinal Health 200, LLC device recall (Cls II)CARDINAL HEALTH INC

Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL — Reason: The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization. — Status: Ongoing

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Dec 26, 2025device recall246d agoGOLD STAR DISTRIBUTION INC device recall (Cls II)

Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS THIN LINERS SCENTED 12CT, ALWAYS ULT.THIN WINGS REG.12/22CT, ALWAYS ULT.THIN OVER NIGHT WINGS 12/16CT, JULIE MAXI NIGHT W.WINGS 36/10CT, STAY FREE REG. 12/10CT, STAY FREE SUPER 24/6CT, TAMPAX REG. 10CT, TAMPAX SUPER 10CT. — Reason: Potential exposure of rodents and rodent activity in the distribution center. — Status: Ongoing

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Dec 26, 2025device recall246d agoGOLD STAR DISTRIBUTION INC device recall (Cls II)

Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4oz/24ct; ADULT TOOTHPASTE W BRUSH (ANTICAV) 6.4oz/24ct. — Reason: Potential exposure of rodents and rodent activity in the distribution center. — Status: Ongoing

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Dec 26, 2025device recall246d agoGOLD STAR DISTRIBUTION INC device recall (Cls II)

Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLUE, TROJAN ULTRA THIN CONDOMS 6/DSP GREY, TROJAN RIBBED CONDOMS 6/DSP GOLD/BROWN, TROJAN NONLUBRICATED CONDOMS 6/DSP RED, TROJAN ULTRA HER PLEASURE CONDOMS 6/DSP, TROJAN CONDOMS MAGNUM 48 CT DISP, *BOX TROJAN CONDOMS MAGNUM 50CT . — Reason: Potential exposure of rodents and rodent activity in the distribution center. — Status: Ongoing

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Dec 26, 2025device recall246d agoGOLD STAR DISTRIBUTION INC device recall (Cls II)

PREGNANCY TEST 24CT — Reason: Potential exposure of rodents and rodent activity in the distribution center. — Status: Ongoing

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Dec 26, 2025device recall246d agoGOLD STAR DISTRIBUTION INC device recall (Cls II)

Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT — Reason: Potential exposure of rodents and rodent activity in the distribution center. — Status: Ongoing

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Week of Dec 29, 2025

29

Dec 29, 2025approval243d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: SUN PHARM INDUSTRIES. Form: TABLET. Route: ORAL

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Dec 29, 2025approval

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