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 Jul 3, 2024
The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mermaid Medical A/S
FDA (openFDA device enforcement)
Reported Jul 3, 2024
NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NovaSignal Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips North America LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diabetes Care, Inc.
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics Inc.
FDA (openFDA device enforcement)
Reported Jul 3, 2024
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sight Diagnostics Ltd.
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
FDA (openFDA device enforcement)
Reported Jul 3, 2024
2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Thoratec Switzerland GmbH
FDA (openFDA device enforcement)
Reported Jun 26, 2024
Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Jun 26, 2024
Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beaver Visitec International, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
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)
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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.