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 Jan 19, 2022
Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Getinge USA Sales Inc.
FDA (openFDA device enforcement)
Reported Jan 19, 2022
OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Haag-Streit USA Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 19, 2022
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ion Beam Applications S.A.
FDA (openFDA device enforcement)
Reported Jan 19, 2022
Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ki Mobility LLC
FDA (openFDA device enforcement)
Reported Jan 19, 2022
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
FDA (openFDA device enforcement)
Reported Jan 19, 2022
Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ohio Medical Corporation
FDA (openFDA device enforcement)
Reported Jan 19, 2022
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 19, 2022
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ptw North America Corporation
FDA (openFDA device enforcement)
Reported Jan 19, 2022
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Reflexion Medical, Inc.
FDA (openFDA device enforcement)
Reported Jan 19, 2022
Regard, T AND A - Rogers, sterilized convenience kits
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
FDA (openFDA device enforcement)
Reported Jan 19, 2022
SOMATOM Confidence -Computed tomography systems Model 10590100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 19, 2022
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Technomed Europe
FDA (openFDA device enforcement)
Reported Jan 12, 2022
Alinity m System, Part No. 08N53-002
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Molecular, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 12, 2022
Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomeme, Inc.
FDA (openFDA device enforcement)
Reported Jan 12, 2022
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DiaSorin Molecular LLC
FDA (openFDA device enforcement)
Reported Jan 12, 2022
Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Flower Orthopedics Corporation
FDA (openFDA device enforcement)
Reported Jan 12, 2022
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
FDA (openFDA device enforcement)
Reported Jan 12, 2022
Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Invacare Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 12, 2022
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medshape, Inc.
FDA (openFDA device enforcement)
Reported Jan 12, 2022
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA (openFDA device enforcement)
Reported Jan 12, 2022
DBB-06 Hemodialysis Delivery System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nikkiso Ltd. - Shizuoka Plant
FDA (openFDA device enforcement)
Reported Jan 12, 2022
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Qiagen Sciences LLC
FDA (openFDA device enforcement)
Reported Jan 12, 2022
Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jan 12, 2022
iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Tapemark Company
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.