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 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)
Reported Dec 20, 2023
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Dec 20, 2023
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bebig Isotopentechnik GmbH
FDA (openFDA device enforcement)
Reported Dec 20, 2023
The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioReference Health, LLC
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Sensica Urine Output System, Catalog Number SCCS1002
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C.R. Bard Inc.
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Change Healthcare Canada Company
FDA (openFDA device enforcement)
Reported Dec 20, 2023
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
FDA (openFDA device enforcement)
Reported Dec 20, 2023
The System is designed as a modular system with components that include an Overhead Tube Suspension with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Hangwei Medical Systems, Co. Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 20, 2023
CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Integra LifeSciences Corp.
FDA (openFDA device enforcement)
Reported Dec 20, 2023
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Limacorporate S.p.A
FDA (openFDA device enforcement)
Reported Dec 20, 2023
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
FDA (openFDA device enforcement)
Reported Dec 20, 2023
STERILE PVP SOLUTION, REF DYNDA1907
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
9 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Medtronic SynchroMed, Model A10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Meridian Bioscience Inc.
2 more products in this recall
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.