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 Nov 20, 2024
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health 200, LLC
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode…
High riskUsing this product could cause serious injury, illness or death — stop using it now.FHC, Inc.
FDA (openFDA device enforcement)
Reported Nov 20, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge USA Sales Inc.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
FDA (openFDA device enforcement)
Reported Nov 20, 2024
CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
10 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Philips Zenition 50, Model Number: 718096
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)
Reported Nov 20, 2024
Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Respironics, Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Metrix Company
15 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Topcon Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Nov 20, 2024
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wissner-Bosserhoff GmbH
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Surgical Company, LLC
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 13, 2024
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Nov 13, 2024
intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biocare Medical, LLC
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
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.