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 Apr 3, 2024
Epix Universal Clip Applier, REF: CA500, STERILEEO
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Applied Medical Resources Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2024
Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2024
Access Substrate, REF 81906, For use with the Access Immunoassay Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Apr 3, 2024
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bio-Rad Laboratories
FDA (openFDA device enforcement)
Reported Apr 3, 2024
RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bolton Medical Inc.
FDA (openFDA device enforcement)
Reported Apr 3, 2024
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2024
Thermalon Eye Compress, Item Number 2434
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bruder Healthcare Company, LLC
8 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2024
GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
High riskUsing this product could cause serious injury, illness or death — stop using it now.DeRoyal Industries Inc.
FDA (openFDA device enforcement)
Reported Apr 3, 2024
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Emergency Products & Research
FDA (openFDA device enforcement)
Reported Apr 3, 2024
stay-safe /Safe Lock Catheter Ext. 12 in
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Medical Care Holdings, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2024
Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Apr 3, 2024
Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.InfuTronix LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2024
IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medical Action Industries, Inc. 306
FDA (openFDA device enforcement)
Reported Apr 3, 2024
Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medivance Inc.
FDA (openFDA device enforcement)
Reported Apr 3, 2024
InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2024
VITROS Performance Verifier I
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2024
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2024
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Puritan Medical Products Company, LLC
FDA (openFDA device enforcement)
Reported Apr 3, 2024
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the 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 Mar 27, 2024
MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
14 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ARROW INTERNATIONAL Inc.
FDA (openFDA device enforcement)
Reported Mar 27, 2024
HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConvaTec, 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.