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 24, 2021
Permobil TiLite, Models: Aero Z, and ZRA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.TiSport, LLC
FDA (openFDA device enforcement)
Reported Nov 17, 2021
Hemodialysis Delivery System, Software Version 2.x.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Nov 17, 2021
T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioCheck, Inc.
FDA (openFDA device enforcement)
Reported Nov 17, 2021
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
FDA (openFDA device enforcement)
Reported Nov 17, 2021
Ellume COVID-19 Home Test
High riskUsing this product could cause serious injury, illness or death — stop using it now.Ellume Ltd.
FDA (openFDA device enforcement)
Reported Nov 17, 2021
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Nov 17, 2021
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Therakos, Inc.
FDA (openFDA device enforcement)
Reported Nov 17, 2021
QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Z-Medica, LLC
FDA (openFDA device enforcement)
Reported Nov 17, 2021
McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zhejiang Kindly Medical Devices Co., Ltd.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 10, 2021
3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.3M Company - Health Care Business
FDA (openFDA device enforcement)
Reported Nov 10, 2021
The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bayer Medical Care, Inc.
FDA (openFDA device enforcement)
Reported Nov 10, 2021
Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 10, 2021
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FujiFilm Healthcare Americas Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 10, 2021
ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Implant Direct Sybron Manufacturing LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 10, 2021
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Jjgc Industria E Comercio De Materials Dentarios Sa
FDA (openFDA device enforcement)
Reported Nov 10, 2021
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
FDA (openFDA device enforcement)
Reported Nov 10, 2021
IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Lumenis, Inc.
FDA (openFDA device enforcement)
Reported Nov 10, 2021
Clinician Programmer Application (CPA) model A610 Clinician Software Application
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Nov 10, 2021
Aspiration Syringe Kit, REF: MVSK60
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microvention Inc.
FDA (openFDA device enforcement)
Reported Nov 10, 2021
COVENA PICC Sleeve
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Queen Comfort Products LLC
FDA (openFDA device enforcement)
Reported Nov 10, 2021
Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Nov 10, 2021
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 10, 2021
Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Nov 10, 2021
Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Windstone Medical Packaging, 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.