All recall categories

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.

Medical devices

Reported Feb 2, 2022

GE Vscan Extend, being sold as "Vscan Extend Console"

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

GE Healthcare, LLC

6 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Feb 2, 2022

1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Nrt X-Ray A/s

FDA (openFDA device enforcement)

Medical devices

Reported Feb 2, 2022

MAGEC 1 System

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

NuVasive Specialized Orthopedics, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Feb 2, 2022

Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Philips Respironics, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Feb 2, 2022

Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Siemens Medical Solutions USA, Inc.

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Feb 2, 2022

PIVO Blood Collection Device 20G, REF: 202-0005

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Velano Vascular

FDA (openFDA device enforcement)

Medical devices

Reported Jan 26, 2022

Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Compass Health Brands (Corporate Office)

FDA (openFDA device enforcement)

Medical devices

Reported Jan 26, 2022

SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Covidien, LP

FDA (openFDA device enforcement)

Medical devices

Reported Jan 26, 2022

Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Draeger Medical, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Jan 26, 2022

Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm)…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

ev3 Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jan 26, 2022

Gentueri Viral Transport Medium (VTM), Sterile, IVD

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Gentueri Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Jan 26, 2022

greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Greiner Bio-One North America, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Jan 26, 2022

ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Konica Minolta Healthcare Americas, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Jan 26, 2022

ARIES HSV 1&2 Assay, Part Number/REF 50-10017

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Luminex Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Jan 26, 2022

KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Microbiologics Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Jan 26, 2022

VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Ortho-Clinical Diagnostics, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Jan 26, 2022

Infa-Therm Transport Mattress, Reference Number 989805616831 1015

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Philips North America LLC

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jan 26, 2022

1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3.…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Siemens Medical Solutions USA, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Jan 26, 2022

Senior Living Arial Emergency and Nurse Call Systems

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Stanley Security Solutions Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Jan 26, 2022

Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Straumann USA LLC

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jan 19, 2022

Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Canon Medical System, USA, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Jan 19, 2022

LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Covidien LLC

FDA (openFDA device enforcement)

Medical devices

Reported Jan 19, 2022

GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

DePuy Orthopaedics, Inc.

7 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jan 19, 2022

Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Gentherm Medical, LLC

FDA (openFDA device enforcement)

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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.