Calendar

Week of Nov 10, 2025

Nov 11, 2025device recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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 recall291d 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, 2025approval290d agoBYOOVIZ (RANIBIZUMAB-NUNA) — FDA approvalBYOOVIZ

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

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Nov 12, 2025approval290d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Nov 12, 2025approval290d agoCLEOCIN T (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: GEL. Route: TOPICAL

full page →CLEOCIN →fda approvals ↗

Nov 12, 2025approval290d agoLOPRESSOR (METOPROLOL TARTRATE) — FDA approvalmetoprolol tartrate

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

full page →metoprolol tartrate →fda approvals ↗

Nov 12, 2025approval290d agoZOVIRAX (ACYCLOVIR) — FDA approvalApotex Corp

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL

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Nov 12, 2025approval290d agoALFUZOSIN HYDROCHLORIDE — FDA approvalInvaGen Pharmaceuticals Inc

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

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Nov 12, 2025approval290d agoALFUZOSIN HYDROCHLORIDE — FDA approvalInvaGen Pharmaceuticals Inc

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

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Nov 12, 2025approval290d agoDEXLANSOPRAZOLE — FDA approvaldexlansoprazole DR

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

full page →dexlansoprazole DR →fda approvals ↗

Nov 12, 2025approval290d agoDIROXIMEL FUMARATE — FDA approvaldiroximel fumarate DR

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

full page →diroximel fumarate DR →fda approvals ↗

Nov 12, 2025approval290d agoCLEOCIN (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: SWAB. Route: TOPICAL

full page →CLEOCIN →fda approvals ↗

Nov 12, 2025approval290d agoIRBESARTAN — FDA approvalIRBESARTAN

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

full page →IRBESARTAN →fda approvals ↗

Nov 12, 2025approval290d agoVALTREX (VALACYCLOVIR HYDROCHLORIDE) — FDA approvalVALACYCLOVIR HYDROCHLORIDE

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →VALACYCLOVIR HYDROCHLORIDE →fda approvals ↗

Nov 12, 2025approval290d agoZOVIRAX (ACYCLOVIR) — FDA approvalApotex Corp

Sponsor: PHARMOBEDIENT. Form: SUSPENSION. Route: ORAL

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Nov 12, 2025approval290d agoZOVIRAX (ACYCLOVIR) — FDA approvalApotex Corp

Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

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Nov 12, 2025approval290d agoTIVDAK (TISOTUMAB VEDOTIN-TFTV) — FDA approvaltisotumab vedotin

Sponsor: SEAGEN. Form: INJECTABLE. Route: INJECTION

full page →tisotumab vedotin →fda approvals ↗

Nov 12, 2025approval290d agoCLEOCIN T (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: LOTION. Route: TOPICAL

full page →CLEOCIN →fda approvals ↗

Nov 12, 2025approval290d agoLEUCOVORIN CALCIUM — FDA approvalLEUCOVORIN CALCIUM

Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

full page →LEUCOVORIN CALCIUM →fda approvals ↗

Nov 12, 2025recall290d 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, 2025recall290d 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, 2025recall290d 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, 2025recall290d 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, 2025recall290d 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 510k290d 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 510k290d agoRevmedx, Inc. — XSTAT P15 (510k cleared)

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

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Nov 12, 2025device 510k290d agoIntrauma S.P.A — WRISTAR MultiAx Distal Radius Kit (510k cleared)

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

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Nov 12, 2025device 510k290d 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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Nov 12, 2025device 510k290d agoSuzhou KD Intelligent Device Co., Ltd. — Powered Wheelchair (PL001-9001) (510k cleared)

Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional

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Week of Nov 10, 2025