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 25, 2024
General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cypress Medical Products LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
ViewPoint; system, imaging processing, radiological
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare GmbH
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
FDA (openFDA device enforcement)
Reported Sep 25, 2024
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Innovasis, Inc.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mazor Robotics Ltd.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Sep 25, 2024
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microvention Inc.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
FDA (openFDA device enforcement)
Reported Sep 25, 2024
HAWK Warming Grid, Item Number: 59-300
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Safeguard US Operating LLC
2 more products in this recall
FDA (openFDA device enforcement)
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)
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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.