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 Sep 25, 2024
Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Seer Medical Pty Ltd.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
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 25, 2024
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tornier, Inc.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Unimax Medical Systems Inc.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
VariSoft Infusion Set, Single Use.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Unomedical A/S
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
High riskUsing this product could cause serious injury, illness or death — stop using it now.B Braun Medical Inc.
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
FDA (openFDA device enforcement)
Reported Sep 18, 2024
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hitachi America, Ltd., Particle Therapy Division
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2024
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ion Beam Applications S.A.
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medical Action Industries, Inc. 306
FDA (openFDA device enforcement)
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)
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.