Calendar

Week of Feb 2, 2026

Feb 4, 2026recall189d agoNOVADOZ PHARMACEUTICALS LLC recall (Cls III)Novadoz Pharmaceuticals LLC

Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72 — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing

full page →fda recalls ↗

Feb 4, 2026recall189d agoGreenstone Llc recall (Cls II)Greenstone LLC

methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2 — Reason: Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil. — Status: Ongoing

full page →fda recalls ↗

Feb 4, 2026recall189d agoSato Pharmaceutical Co., Ltd recall (Cls II)TAKEDA PHARMACEUTICAL CO LTD

INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01 — Reason: Failed Disintegration Specifications: above the time expected. — Status: Ongoing

full page →fda recalls ↗

Feb 4, 2026device 510k189d agoOrthosoft Inc. (d/b/a) Zimmer CAS — Signature ONE System (510k cleared)

Product code: QHE. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗

Feb 4, 2026device 510k189d agoSpinal Elements, Inc. — Luna® Ti Interbody Fusion System (510k cleared)

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

full page →fda device 510k ↗

Feb 4, 2026device 510k189d agoBard Peripheral Vascular, Inc. — UltraScore Focused Force PTA Balloon (510k cleared)

Product code: PNO. Advisory committee: Cardiovascular. Type: Special

full page →fda device 510k ↗

Feb 4, 2026device 510k189d agoZimmer, Inc. — G7® Revision Acetabular System (510k cleared)

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

full page →fda device 510k ↗

Feb 4, 2026device 510k189d agoYadu Medical (Henan) Co., Ltd. — Henan Yadu Level 4 Surgical Gowns (Reinforced) (510k cleared)

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

full page →fda device 510k ↗

Feb 4, 2026device 510k189d agoEvolution Spine — E3D-C Interbody System (510k cleared)

Product code: OVE. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗

Feb 4, 2026device pma189d agoInstylla, Inc. — Embrace Hydrogel Embolic System (PMA supplement)

Supplement type: 30-Day Notice. Product code: QVG. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Feb 4, 2026device pma189d agoMedinol, Ltd. — EluNIR Ridaforolimus Eluting Coronary Stent System (PMA supplement)IGC Pharma, Inc.

Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Feb 4, 2026device pma189d agoMentor Corp. — MENTOR MemoryGel Breast Implants (PMA supplement)

Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Feb 4, 2026device pma189d agoMentor Worldwide, LLC — MENTOR MemoryShape Breast Implants (PMA supplement)

Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Feb 4, 2026device pma189d agoMentor Worldwide, LLC — MENTOR Saline-Filled and SPECTRUM Breast Implants (PMA supplement)Revalesio Corp

Supplement type: 30-Day Notice. Product code: FWM. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Feb 4, 2026device pma189d agoGuardant Health, Inc. — Shield (PMA supplement)Guardant Health, Inc.

Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: MG. Decision: OK30

full page →fda device pma ↗

Feb 4, 2026device pma189d agoMedtronic, Inc. — Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve (EVOLUTPRO-23-US, EVOLUTPRO-26-US, EVOLUTPRO-29-US); Medtron (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Feb 4, 2026device pma189d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (PMA supplement)

Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Feb 4, 2026device pma189d agoMedtronic, Inc. — Avalus Bioprosthesis Model 400 (40019, 40021, 40023, 40025, 40027, 40029); Avalus Ultra Bioprosthesis Model 400 (400U1 (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Feb 4, 2026device recall189d agoDiagnostica Stago, Inc. device recall (Cls II)

Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable — Reason: The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values. — Status: Ongoing

full page →fda device recalls ↗

Feb 4, 2026grant189d agoUNIVERSITY OF CALIFORNIA, SAN DIEGO — Discovery and evolution of mammalian Serpins as host-encoded viral protease i...University of California San Diego

AI grant. $439,250. PI: Matthew Daugherty

Week of Feb 2, 2026