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 Sep 18, 2024
Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) ULTRASOUND GUIDED PIV KIT, Pack…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
105 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2024
25-LHP-828, HeNe Laser System, 35 mW
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pacific Lasertech, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2024
ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Pneupac paraPAC plus 300 ventilator kit, REF P300NXX
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sol-Millennium Medical Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2024
NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Technomed Europe
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ultradent Products, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zoe Medical Incorporated
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2024
Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
17 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2024
Power Express, REF B90918
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Biomedical GmbH
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2024
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Sep 11, 2024
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Breas Medical, Inc.
FDA (openFDA device enforcement)
Reported Sep 11, 2024
BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2024
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
FDA (openFDA device enforcement)
Reported Sep 11, 2024
Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mindray DS USA, Inc. dba Mindray North America
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2024
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
FDA (openFDA device enforcement)
Reported Sep 11, 2024
Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Respironics, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2024
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W L Gore & Associates, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Free recall alerts
Get alerted about new Medical device recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.
Related categories
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.