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 Jan 3, 2024
Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 3, 2024
Medtronic SynchroMed II, Model 8637-20, Programmable pump
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 3, 2024
Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
High riskUsing this product could cause serious injury, illness or death — stop using it now.Megadyne Medical Products, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 3, 2024
Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CardioQuip, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
AcuMatch Hip System, Catalog Number 142-32-27
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Inpeco S.A.
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Injection Needle, REF: 25207
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
FDA (openFDA device enforcement)
Reported Dec 27, 2023
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Maquet Medical Systems USA
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Nurse Assist, LLC
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Dec 27, 2023
AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Physio-Control, Inc.
FDA (openFDA device enforcement)
Reported Dec 27, 2023
AirFit N10 Nasal Masks and User Guide
High riskUsing this product could cause serious injury, illness or death — stop using it now.ResMed Ltd.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
LITe Decompression Snake Arm, REF 48080230
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Spine
FDA (openFDA device enforcement)
Reported Dec 27, 2023
VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vero Biotech, LLC
FDA (openFDA device enforcement)
Reported Dec 27, 2023
ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zeus Scientific, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Navik 3D v2, REF NAVIK3D, 3D Mapping System
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.APN Health LLC
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.