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 Sep 3, 2025
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet GmbH
FDA (openFDA device enforcement)
Reported Sep 3, 2025
The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
8 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
FDA (openFDA device enforcement)
Reported Sep 3, 2025
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Onkos Surgical, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
Orascoptic Superior Visualization Custom loupes with Dragonfly frames
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Orascoptic Surgical Acuity
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
3D6-2 Transducer Probe
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Philips Ultrasound, Inc.
68 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Tandem Diabetes Care, Inc.
FDA (openFDA device enforcement)
Reported Sep 3, 2025
Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.THOR Photomedicine Ltd.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vantive US Healthcare LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zhejiang Luyao Electronics Technology Co., Ltd.
FDA (openFDA device enforcement)
Reported Aug 27, 2025
ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 27, 2025
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Neuromodulation Corporation
FDA (openFDA device enforcement)
Reported Aug 27, 2025
Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Drs Vascular, Inc.
FDA (openFDA device enforcement)
Reported Aug 27, 2025
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dynex Technologies, Inc.
FDA (openFDA device enforcement)
Reported Aug 27, 2025
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hamilton Medical AG
FDA (openFDA device enforcement)
Reported Aug 27, 2025
Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Immunotech A.S.
FDA (openFDA device enforcement)
Reported Aug 27, 2025
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lumenis, Ltd.
FDA (openFDA device enforcement)
Reported Aug 27, 2025
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mckesson Medical-Surgical Inc. Corporate Office
FDA (openFDA device enforcement)
Reported Aug 27, 2025
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform…
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 Aug 27, 2025
VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Aug 27, 2025
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pentax
FDA (openFDA device enforcement)
Reported Aug 27, 2025
Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spiggle & Theis Mt GmbH
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Ambu Inc.
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
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.