Calendar

Week of Nov 10, 2025

Nov 11, 2025device recall278d 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 recall278d 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 recall278d 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 recall278d 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 recall278d 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 recall278d 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 recall278d 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 recall278d 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 recall278d 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 recall278d 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 recall278d 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 recall278d 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 recall278d 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 recall278d 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 recall278d 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 recall278d 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, 2025approval277d agoBYOOVIZ (RANIBIZUMAB-NUNA) — FDA approvalBYOOVIZ

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

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Nov 12, 2025approval277d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Nov 12, 2025approval277d agoCLEOCIN T (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: GEL. Route: TOPICAL

full page →CLEOCIN →fda approvals ↗

Nov 12, 2025approval277d agoLOPRESSOR (METOPROLOL TARTRATE) — FDA approvalmetoprolol tartrate

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

full page →metoprolol tartrate →fda approvals ↗

Nov 12, 2025approval277d agoZOVIRAX (ACYCLOVIR) — FDA approvalApotex Corp

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL

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Nov 12, 2025approval277d agoALFUZOSIN HYDROCHLORIDE — FDA approvalInvaGen Pharmaceuticals Inc

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

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Nov 12, 2025approval277d agoALFUZOSIN HYDROCHLORIDE — FDA approvalInvaGen Pharmaceuticals Inc

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

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Nov 12, 2025approval277d agoDEXLANSOPRAZOLE — FDA approvaldexlansoprazole DR

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

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Nov 12, 2025approval277d agoDIROXIMEL FUMARATE — FDA approvaldiroximel fumarate DR

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

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Nov 12, 2025approval277d agoCLEOCIN (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: SWAB. Route: TOPICAL

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Nov 12, 2025approval277d agoIRBESARTAN — FDA approvalIRBESARTAN

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

full page →IRBESARTAN →fda approvals ↗

Nov 12, 2025approval277d agoVALTREX (VALACYCLOVIR HYDROCHLORIDE) — FDA approvalVALACYCLOVIR HYDROCHLORIDE

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →VALACYCLOVIR HYDROCHLORIDE →fda approvals ↗

Nov 12, 2025approval277d agoZOVIRAX (ACYCLOVIR) — FDA approvalApotex Corp

Sponsor: PHARMOBEDIENT. Form: SUSPENSION. Route: ORAL

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Nov 12, 2025approval277d agoZOVIRAX (ACYCLOVIR) — FDA approvalApotex Corp

Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

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Nov 12, 2025approval277d agoTIVDAK (TISOTUMAB VEDOTIN-TFTV) — FDA approvaltisotumab vedotin

Sponsor: SEAGEN. Form: INJECTABLE. Route: INJECTION

full page →tisotumab vedotin →fda approvals ↗

Nov 12, 2025approval277d agoCLEOCIN T (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: LOTION. Route: TOPICAL

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Nov 12, 2025approval277d agoLEUCOVORIN CALCIUM — FDA approvalLEUCOVORIN CALCIUM

Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

full page →LEUCOVORIN CALCIUM →fda approvals ↗

Nov 12, 2025recall277d 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, 2025recall277d 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, 2025recall277d 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, 2025recall277d 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, 2025recall277d 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 510k277d 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 510k277d agoRevmedx, Inc. — XSTAT P15 (510k cleared)

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

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Nov 12, 2025device 510k277d 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 510k277d 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 510k277d 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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Nov 12, 2025device 510k277d agoOlympus Medical Systems Corp. — VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) (510k cleared)

Product code: OWN. Advisory committee: Gastroenterology, Urology. Type: Traditional

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Nov 12, 2025device 510k277d agoETHICON, Inc. — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture (510k cleared)

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

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Nov 12, 2025device 510k277d agoPeek Health, S.A. — PeekMed web (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Traditional

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Nov 12, 2025device 510k277d agoSynthes GmbH — Synthes Patient Specific Implants (510k cleared)

Product code: GXN. Advisory committee: Neurology. Type: Traditional

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Nov 12, 2025device 510k277d agoHangzhou AGS MedTech Co., Ltd. — Hemoclip (510k cleared)

Product code: PKL. Advisory committee: Gastroenterology, Urology. Type: Traditional

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Nov 12, 2025device pma277d agoGraphic Controls D.B.A. Vermed — HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: APPR

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Nov 12, 2025device recall277d agoHowmedica Osteonics Corp. device recall (Cls II)

The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration. — Reason: When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device. — Status: Ongoing

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Week of Nov 10, 2025