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Week of Mar 2, 2026

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Mar 3, 2026device pma165d agoMedtronic, Inc. — Mosaic Neo Mitral Bioprosthesis (PMA supplement)Medtronic plc

Supplement type: Normal 180 Day Track. Product code: DYE. Advisory committee: CV. Decision: APPR

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Mar 3, 2026device pma165d agoPerimeter Medical Imaging Ai, Inc. — Claire OCT System (PMA)

Product code: SHH. Advisory committee: SU. Decision: APPR

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Mar 3, 2026device pma165d agoMedtronic, Inc. — HexaGen RF Generator (PMA supplement)Medtronic plc

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

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Mar 3, 2026device pma165d agoValencia Technologies Corporation — eCoin Peripheral Neurostimulator (PMA supplement)

Supplement type: Normal 180 Day Track No User Fee. Product code: QPT. Advisory committee: GU. Decision: APPR

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/15 OR Table; System Code: 722059; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 5 M12; System Code: (1)722227, (2)722231; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoOxoid Australia Pty Limited device recall (Cls II)THERMO FISHER SCIENTIFIC INC.

OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem — Reason: Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD10F; System Code: 722002; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/10; System Code: 722029; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only); — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/20 OR Table; System Code: 722039; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/15; System Code: 722058; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/20; System Code: 722038; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only); — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD10C; System Code: 722001; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall165d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026grant165d agoVANDERBILT UNIVERSITY — Transcranial Functional Ultrasound in Adult Humans

EB grant. $542,947. PI: Brett C Byram

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Mar 3, 2026grant165d agoUNIVERSITY OF MISSISSIPPI — Ionic liquid-assisted drug delivery to brain reservoirs for treatment of neur...

DA grant. $101,214. PI: Jason Richard Paris

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Mar 3, 2026grant165d agoGORDON RESEARCH CONFERENCES — 2026 Immunoengineering Gordon Research Conference and Gordon Research Seminar

AI grant. $19,000. PI: Nicole Franziska Steinmetz

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Mar 3, 2026grant165d agoKEYSTONE SYMPOSIA — RNA Modifications: Bridging Biological Function and Therapeutic Potential

CA grant. $10,000. PI: TERRY L. SHEPPARD

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Mar 3, 2026grant165d agoMAYO CLINIC ROCHESTER — Acute Kidney Injury in Care Transitions: The ACT Pragmatic TrialMayo Clinic

DK grant. $796,370. PI: Erin Frazee Barreto

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Mar 3, 2026grant165d agoKEYSTONE SYMPOSIA — Cancer Immunotherapy: Basic Mechanisms Informing Clinical Applications & Comb...

CA grant. $5,000. PI: TERRY L. SHEPPARD

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Mar 3, 2026grant165d agoMICHIGAN STATE UNIVERSITY — Probing nucleolus function in a mouse model of fragile X syndrome

MH grant. $416,859. PI: Hongbing Wang

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Mar 3, 2026grant165d agoUNIVERSITY OF CALIFORNIA, SAN DIEGO — Functional RNA elements in the human genomeUniversity of California San Diego

HG grant. $785,329. PI: Kevin Daniel Corbett

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Mar 4, 2026approval164d agoBAL (DIMERCAPROL) — FDA approvalAkorn Operating Company LLC (Inactive)

Sponsor: PROVEPHARM SAS. Form: INJECTABLE. Route: INJECTION

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Mar 4, 2026approval164d agoROCURONIUM BROMIDE — FDA approvalROCURONIUM BROMIDE

Sponsor: ASPIRO. Form: INJECTABLE. Route: INJECTION

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Mar 4, 2026approval164d agoEMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE (EMTRICITABINE) — FDA approvalHetero USA Inc

Sponsor: LAURUS. Form: TABLET. Route: ORAL

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Mar 4, 2026approval164d agoCALCITONIN-SALMON (CALCITONIN SALMON) — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: INJECTABLE. Route: INJECTION

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Mar 4, 2026approval164d agoDESIPRAMINE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS CO. Form: TABLET. Route: ORAL

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Mar 4, 2026approval164d agoGLIPIZIDE — FDA approvalGraviti Pharmaceuticals Inc

Sponsor: GRAVITI PHARMS. Form: TABLET. Route: ORAL

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Mar 4, 2026recall164d agoWizcure Pharmaa Private Limited recall (Cls II)

BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing

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Mar 4, 2026recall164d agoWizcure Pharmaa Private Limited recall (Cls II)

Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing

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Mar 4, 2026recall164d agoWizcure Pharmaa Private Limited recall (Cls II)

Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing

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Mar 4, 2026recall164d agoSlate Run Pharmaceuticals recall (Cls III)Slate Run Pharmaceuticals LLC

Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80 — Reason: Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion. — Status: Ongoing

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Mar 4, 2026recall164d agoAvKARE recall (Cls II)AvKare LLC

Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15. — Reason: Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution. — Status: Ongoing

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Mar 4, 2026recall164d agoWizcure Pharmaa Private Limited recall (Cls II)

Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing

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Mar 4, 2026recall164d agoLEO PHARMA INC recall (Cls II)IGC Pharma, Inc.

Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA, — Reason: Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber. — Status: Ongoing

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Mar 4, 2026recall164d agoWizcure Pharmaa Private Limited recall (Cls II)

Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing

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Mar 4, 2026recall164d agoAgebox recall (Cls II)Children’s Hospital of Chongqing Medical University

Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027 — Reason: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren — Status: Ongoing

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