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 Sep 10, 2025
RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Reflexion Medical, Inc.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Visgeneer, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems Inc.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Bausch & Lomb Surgical, Inc.
FDA (openFDA device enforcement)
Reported Sep 3, 2025
Spectrum IQ Infusion Pump, Product Code 3570009
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bd Switzerland Sarl
FDA (openFDA device enforcement)
Reported Sep 3, 2025
Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C.R. Bard Inc.
FDA (openFDA device enforcement)
Reported Sep 3, 2025
BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis"…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Sep 3, 2025
Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dentsply IH, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diagnostica Stago, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
GE HealthCare OEC 9800.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
1 more product in this recall
FDA (openFDA device enforcement)
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)
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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.