Calendar

Week of Nov 10, 2025

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

full page →BYOOVIZ →fda approvals ↗

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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Nov 12, 2025recall278d agoZydus Pharmaceuticals (USA) Inc recall (Cls II)LB PHARMACEUTICALS INC

clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India — Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. — Status: Ongoing

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Nov 12, 2025recall278d agoZydus Pharmaceuticals (USA) Inc recall (Cls II)LB PHARMACEUTICALS INC

clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India — Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. — Status: Ongoing

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Nov 12, 2025recall278d agoZydus Pharmaceuticals (USA) Inc recall (Cls II)LB PHARMACEUTICALS INC

clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. — Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. — Status: Ongoing

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Nov 12, 2025device 510k278d agoIcotec AG — CMORE® CT System; CMORE® CT System Navigated Instruments (510k cleared)

Product code: NKG. Advisory committee: Orthopedic. Type: Traditional

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Nov 12, 2025device 510k278d agoRevmedx, Inc. — XSTAT P15 (510k cleared)

Product code: PGZ. Advisory committee: General, Plastic Surgery. Type: Traditional

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Nov 12, 2025device 510k278d agoIntrauma S.P.A — WRISTAR MultiAx Distal Radius Kit (510k cleared)

Product code: HRS. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗

Nov 12, 2025device 510k278d agoEncore Medical L.P. — EMPOWR Acetabular® Liner Extension (510k cleared)Encore Medical, Inc.

Product code: LPH. Advisory committee: Orthopedic. Type: Traditional

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Week of Nov 10, 2025