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 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)
Reported Mar 27, 2024
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
Moderate riskThis product could cause temporary or reversible health problems — stop using it.In2Bones, SAS
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Landauer
FDA (openFDA device enforcement)
Reported Mar 27, 2024
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mc3 Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mckesson Medical-Surgical Inc. Corporate Office
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Medtronic DLP Vessel Cannula, Model Number REF 30000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
FDA (openFDA device enforcement)
Reported Mar 27, 2024
TENSIVE Conductive Adhesive Gel, REF 016-401600
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Natus Neurology Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preat Corp.
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories 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.