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 Jun 1, 2022
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 1, 2022
Surgical Suture Kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stradis Healthcare
FDA (openFDA device enforcement)
Reported Jun 1, 2022
(1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 1, 2022
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Umano Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 25, 2022
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abbott Vascular
FDA (openFDA device enforcement)
Reported May 25, 2022
Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Atrium Medical Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 25, 2022
Avanos Cortrak 2 Enteral Access System (EAS)
High riskUsing this product could cause serious injury, illness or death — stop using it now.Avanos Medical, Inc.
FDA (openFDA device enforcement)
Reported May 25, 2022
NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls,…
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 May 25, 2022
MicroScan WalkAway-40 plus Instrument REF B1018-283
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 25, 2022
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bio-Rad Laboratories, Inc.
FDA (openFDA device enforcement)
Reported May 25, 2022
EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 25, 2022
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Caire, Inc.
FDA (openFDA device enforcement)
Reported May 25, 2022
Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Clinician's Choice Dental Products Inc.
FDA (openFDA device enforcement)
Reported May 25, 2022
VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
FDA (openFDA device enforcement)
Reported May 25, 2022
Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge USA Sales Inc.
FDA (openFDA device enforcement)
Reported May 25, 2022
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Heartware, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 25, 2022
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Luminex Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 25, 2022
Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
FDA (openFDA device enforcement)
Reported May 25, 2022
ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Neuralynx Inc.
FDA (openFDA device enforcement)
Reported May 25, 2022
Olympus Uretero-reno videoscope, Model No. URF-V2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported May 25, 2022
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 25, 2022
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Radiometer Medical ApS
FDA (openFDA device enforcement)
Reported May 25, 2022
CK MB Calibrator, Catalogue Number CK2393
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Randox Laboratories Ltd.
FDA (openFDA device enforcement)
Reported May 25, 2022
LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew 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.