All recall categories

Medical device recalls

Device recalls are the largest single group in this archive, because the FDA logs corrections and removals as well as outright withdrawals. Many are handled entirely between the manufacturer and a hospital and need nothing from a patient. Each notice states who has to act.

13,634 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.

Medical devices

Reported Jun 24, 2026

Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic Navigation, Inc.-Boxborough

FDA (openFDA device enforcement)

Medical devices

Reported Jun 24, 2026

Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF:…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Jun 24, 2026

Mito Red Light, Super Mobile

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Mito Red Light Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Jun 24, 2026

Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Philips Medical Systems Nederland B.v.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 24, 2026

TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Smith & Nephew, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Jun 24, 2026

Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Staar Surgical AG

FDA (openFDA device enforcement)

Medical devices

Reported Jun 24, 2026

HarmonyAIR A-Series Surgical Lighting System

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Steris Corporation

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 24, 2026

Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Thoratec LLC

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 17, 2026

Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Abbott Medical

FDA (openFDA device enforcement)

Medical devices

Reported Jun 17, 2026

Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Avanos Medical, Inc.

19 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 17, 2026

Halyard, Pain Pack. Kit Code: AMPK48-01.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

AVID Medical, Inc.

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 17, 2026

EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF:…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Berlin Heart GmbH

FDA (openFDA device enforcement)

Medical devices

Reported Jun 17, 2026

Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Boston Scientific Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Jun 17, 2026

Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF:…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Boston Scientific Neuromodulation Corporation

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 17, 2026

TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

D.O.R.C. Dutch Opthalmic Research Center Intl B.V.

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 17, 2026

Hintermann Series Talar Implant, Left, Size 2 REF 302112

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

DT MedTech, LLC

FDA (openFDA device enforcement)

Medical devices

Reported Jun 17, 2026

MOSAIQ Oncology Information System

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Elekta, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Jun 17, 2026

Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Fresenius Medical Care Holdings, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 17, 2026

Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Fresh Roast Systems Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Jun 17, 2026

Allia IGS 3 Pulse angiographic X-ray system

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

GE Medical Systems, LLC

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 17, 2026

Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

HF Acquisition Co. LLC

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 17, 2026

Plum Solo Precision IV Pump, 40001-0401

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

ICU Medical, Inc.

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 17, 2026

NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElastic…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

In2bones USA, LLC

FDA (openFDA device enforcement)

Medical devices

Reported Jun 17, 2026

Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

INSPIREMD Inc.

5 more products in this recall

FDA (openFDA device enforcement)

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Related categories

RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.