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 Oct 6, 2021
The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vascutek, Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 6, 2021
GENOSYL DS (Delivery System) console, for use as a vasodilator.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Vero Biotech, LLC
FDA (openFDA device enforcement)
Reported Oct 6, 2021
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.WOM World
FDA (openFDA device enforcement)
Reported Sep 29, 2021
Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ad-Tech Medical Instrument Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 29, 2021
Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
7 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 29, 2021
EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion…
High riskUsing this product could cause serious injury, illness or death — stop using it now.AMTEC SALES Inc.
FDA (openFDA device enforcement)
Reported Sep 29, 2021
Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Argon Medical Devices, Inc.
FDA (openFDA device enforcement)
Reported Sep 29, 2021
Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Sep 29, 2021
Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C.R. Bard Inc.
20 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 29, 2021
DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConvaTec, Inc.
FDA (openFDA device enforcement)
Reported Sep 29, 2021
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 29, 2021
Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Greiner Bio-One North America, Inc.
FDA (openFDA device enforcement)
Reported Sep 29, 2021
CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.In2bones USA, LLC
FDA (openFDA device enforcement)
Reported Sep 29, 2021
Bone Marrow Transplantation biopsy needle
Moderate riskThis product could cause temporary or reversible health problems — stop using it.M.D.L. S.r.l.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 29, 2021
Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Mac Medical Supply Co. Inc.
FDA (openFDA device enforcement)
Reported Sep 29, 2021
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 29, 2021
SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to…
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 Sep 29, 2021
10 ga ARS Decompression Needle, Part Number ZZ-0298
Moderate riskThis product could cause temporary or reversible health problems — stop using it.North American Rescue LLC.
FDA (openFDA device enforcement)
Reported Sep 29, 2021
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Sep 29, 2021
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Paragon 28, Inc.
FDA (openFDA device enforcement)
Reported Sep 29, 2021
EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 29, 2021
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Molecular Systems, Inc.
FDA (openFDA device enforcement)
Reported Sep 29, 2021
Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Sep 29, 2021
Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sight Diagnostics Ltd.
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.