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 Jun 26, 2024
Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C.R. Bard Inc.
FDA (openFDA device enforcement)
Reported Jun 26, 2024
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 26, 2024
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 26, 2024
Ventilator HAMILTON-C6, PN: 160021
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hamilton Medical AG
FDA (openFDA device enforcement)
Reported Jun 26, 2024
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 26, 2024
NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NxStage Medical Inc.
FDA (openFDA device enforcement)
Reported Jun 26, 2024
TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Outset Medical, Inc.
FDA (openFDA device enforcement)
Reported Jun 26, 2024
ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ZOLL Medical Corporation
FDA (openFDA device enforcement)
Reported Jun 19, 2024
Aeos Robotic Digital Microscope, Product Code: PV010
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Inc.
FDA (openFDA device enforcement)
Reported Jun 19, 2024
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Avanos Medical, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 19, 2024
Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B Braun Medical Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 19, 2024
CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Blue Belt Technologies, Inc.
FDA (openFDA device enforcement)
Reported Jun 19, 2024
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
FDA (openFDA device enforcement)
Reported Jun 19, 2024
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LLC
FDA (openFDA device enforcement)
Reported Jun 19, 2024
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported Jun 19, 2024
MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
FDA (openFDA device enforcement)
Reported Jun 19, 2024
CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 19, 2024
Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mckesson Medical-Surgical Inc. Corporate Office
FDA (openFDA device enforcement)
Reported Jun 19, 2024
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jun 19, 2024
OMTech Desktop Laser Engraver
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Rygel Advanced Machines d/b/a Omtech Laser
FDA (openFDA device enforcement)
Reported Jun 19, 2024
Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Thoratec Corp.
FDA (openFDA device enforcement)
Reported Jun 19, 2024
Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wondfo USA Co. Ltd.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 19, 2024
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Young Dental Manufacturing I, LLC
FDA (openFDA device enforcement)
Reported Jun 12, 2024
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
High riskUsing this product could cause serious injury, illness or death — stop using it now.ARROW INTERNATIONAL Inc.
2 more products in this recall
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.