Calendar

Week of Nov 10, 2025

Nov 10, 2025device pma280d agoMedtronic, Inc. — Avalus Bioprosthesis, Avalus Ultra Bioprosthesis (PMA supplement)Medtronic plc

Supplement type: Real-Time Process. Product code: LWR. Advisory committee: CV. Decision: APPR

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Nov 10, 2025device recall280d agoBeckman Coulter, Inc. device recall (Cls II)

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent. — Reason: Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers. — Status: Ongoing

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Nov 10, 2025device recall280d agoDraeger, Inc. device recall (Cls I)Traeger, Inc.

ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient. — Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. — Status: Ongoing

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Nov 10, 2025device recall280d agoDraeger, Inc. device recall (Cls I)Traeger, Inc.

ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient. — Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. — Status: Ongoing

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Nov 10, 2025device recall280d agoDraeger, Inc. device recall (Cls I)Traeger, Inc.

ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient. — Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. — Status: Ongoing

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Nov 10, 2025device recall280d agoWaldemar Link GmbH & Co. KG (Mfg Site) device recall (Cls II)

Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices. — Reason: The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component. — Status: Ongoing

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Nov 10, 2025device recall280d agoDraeger, Inc. device recall (Cls I)Traeger, Inc.

ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient. — Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoAVID Medical, Inc. device recall (Cls I)AVITA Medical, Inc.

Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17. — Reason: Devices are not suitable for organ transplant. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoAVID Medical, Inc. device recall (Cls I)AVITA Medical, Inc.

Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15. — Reason: Devices are not suitable for organ transplant. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoMedline Industries, LP device recall (Cls II)

DEXLOCK Achilles Repair Implant Kits, MAKT4520 — Reason: There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure. — Status: Ongoing

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Nov 11, 2025device recall279d agoAVID Medical, Inc. device recall (Cls I)AVITA Medical, Inc.

Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08 — Reason: Devices are not suitable for organ transplant. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 11, 2025device recall279d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing

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Nov 12, 2025approval278d agoBYOOVIZ (RANIBIZUMAB-NUNA) — FDA approvalBYOOVIZ

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

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Nov 12, 2025approval278d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Nov 12, 2025approval278d agoCLEOCIN T (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: GEL. Route: TOPICAL

full page →CLEOCIN →fda approvals ↗

Nov 12, 2025approval278d agoLOPRESSOR (METOPROLOL TARTRATE) — FDA approvalmetoprolol tartrate

Sponsor: RUBICON RESEARCH. Form: SOLUTION. Route: ORAL

full page →metoprolol tartrate →fda approvals ↗

Nov 12, 2025approval278d agoZOVIRAX (ACYCLOVIR) — FDA approvalApotex Corp

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL

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Nov 12, 2025approval278d agoALFUZOSIN HYDROCHLORIDE — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: INVAGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

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Nov 12, 2025approval278d agoALFUZOSIN HYDROCHLORIDE — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: INVAGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

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Nov 12, 2025approval278d agoDEXLANSOPRAZOLE — FDA approvaldexlansoprazole DR

Sponsor: ALEMBIC. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

full page →dexlansoprazole DR →fda approvals ↗

Nov 12, 2025approval278d agoDIROXIMEL FUMARATE — FDA approvaldiroximel fumarate DR

Sponsor: ZYDUS. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

full page →diroximel fumarate DR →fda approvals ↗

Nov 12, 2025approval278d agoCLEOCIN (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: SWAB. Route: TOPICAL

full page →CLEOCIN →fda approvals ↗

Nov 12, 2025approval278d agoIRBESARTAN — FDA approvalIRBESARTAN

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL

full page →IRBESARTAN →fda approvals ↗

Nov 12, 2025approval278d agoVALTREX (VALACYCLOVIR HYDROCHLORIDE) — FDA approvalVALACYCLOVIR HYDROCHLORIDE

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →VALACYCLOVIR HYDROCHLORIDE →fda approvals ↗

Nov 12, 2025approval278d agoZOVIRAX (ACYCLOVIR) — FDA approvalApotex Corp

Sponsor: PHARMOBEDIENT. Form: SUSPENSION. Route: ORAL

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Nov 12, 2025approval278d agoZOVIRAX (ACYCLOVIR) — FDA approvalApotex Corp

Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

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Nov 12, 2025approval278d agoTIVDAK (TISOTUMAB VEDOTIN-TFTV) — FDA approvaltisotumab vedotin

Sponsor: SEAGEN. Form: INJECTABLE. Route: INJECTION

full page →tisotumab vedotin →fda approvals ↗

Nov 12, 2025approval278d agoCLEOCIN T (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: LOTION. Route: TOPICAL

full page →CLEOCIN →fda approvals ↗

Nov 12, 2025approval278d agoLEUCOVORIN CALCIUM — FDA approvalLEUCOVORIN CALCIUM

Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

full page →LEUCOVORIN CALCIUM →fda approvals ↗

Nov 12, 2025recall278d agoTeva Pharmaceuticals USA, Inc recall (Cls II)Terns Pharmaceuticals, Inc.

Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7. — Reason: Subpotent drug; Clavulanate Potassium component — Status: Ongoing

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Nov 12, 2025recall278d agoAero Healthcare recall (Cls II)IGC Pharma, Inc.

Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01 — Reason: Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg. — Status: Ongoing

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Week of Nov 10, 2025