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.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Feb 26, 2025
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
10 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2025
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remel, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2025
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Spectranetics Corporation
FDA (openFDA device enforcement)
Reported Feb 26, 2025
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE))…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.XTANT Medical Holdings, Inc.
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angel Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
11 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 19, 2025
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 19, 2025
MOSAIQ Oncology Information System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta, Inc.
FDA (openFDA device enforcement)
Reported Feb 19, 2025
AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM…
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)
Reported Feb 19, 2025
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Getinge USA Sales Inc.
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.HF Acquisition Co. LLC
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
FDA (openFDA device enforcement)
Reported Feb 19, 2025
The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ithera Medical GmbH
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Max Mobility LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 19, 2025
MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microvention Inc.
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Murata Vios, Inc.
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Feb 19, 2025
stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Belmont Instrument LLC
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Temporary Titanium Abutments
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DDS Lab
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.