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 Jul 31, 2024
BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Embecta Corp.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Link Bio Corp.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Jul 31, 2024
TourniKwik Tourniquet Set (CFN 79012)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
FDA (openFDA device enforcement)
Reported Jul 31, 2024
NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Xomed, Inc.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Jul 31, 2024
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Radiometer Medical ApS
FDA (openFDA device enforcement)
Reported Jul 31, 2024
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Securitas Healthcare LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 31, 2024
Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Medical
11 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
FDA (openFDA device enforcement)
Reported Jul 24, 2024
OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
28 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara.…
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 Jul 24, 2024
BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton, Dickinson and Company, BD Biosciences
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Cascade IOMAX Cortical Module, REF: 190296-200
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cadwell Industries Inc.
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canadian Hospital Specialties Ltd.
FDA (openFDA device enforcement)
Reported Jul 24, 2024
BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Jul 24, 2024
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon Sarl, a Johnson & Johnson Company
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2024
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Greiner Bio-One North America, Inc.
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic Inc.
FDA (openFDA device enforcement)
Reported Jul 24, 2024
UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
2 more products in this recall
FDA (openFDA device enforcement)
Free recall alerts
Get alerted about new Medical device recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.
Related categories
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.