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.
Reported Dec 3, 2025
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Foundation Medicine, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Glycar SA Pty., Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
FlexLab (FLX); Version: FLX-217-10;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Inpeco S.A.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
IntelePACS - InteleConnect / TechPortal
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intelerad Medical Systems Incorporated
FDA (openFDA device enforcement)
Reported Dec 3, 2025
The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Magellan Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Dec 3, 2025
CareLink Clinic, REF: MMT-7350
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mindray DS USA, Inc. dba Mindray North America
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Noah Medical Corporation
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pivotal Health Solutions, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remel, Inc.
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Straumann USA LLC
FDA (openFDA device enforcement)
Reported Dec 3, 2025
NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 26, 2025
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ASP Global, LLC. dba Anatomy Supply Partners, LLC.
23 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 26, 2025
MONARCH Bronchoscope. Model Number: MBR-000211-B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Auris Health, Inc.
FDA (openFDA device enforcement)
Reported Nov 26, 2025
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Nov 26, 2025
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
FDA (openFDA device enforcement)
Reported Nov 26, 2025
Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Berkeley Advanced Biomaterials, LLC
FDA (openFDA device enforcement)
Reported Nov 26, 2025
BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Nov 26, 2025
REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cellavision AB
FDA (openFDA device enforcement)
Reported Nov 26, 2025
MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta Solutions Ab
FDA (openFDA device enforcement)
Reported Nov 26, 2025
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
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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.