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 Feb 16, 2022
KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Microbiologics Inc.
10 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 16, 2022
R82 by ETAC Push Brace for High-Low
Moderate riskThis product could cause temporary or reversible health problems — stop using it.R82 A/s
FDA (openFDA device enforcement)
Reported Feb 16, 2022
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
FDA (openFDA device enforcement)
Reported Feb 16, 2022
Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
FDA (openFDA device enforcement)
Reported Feb 9, 2022
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
FDA (openFDA device enforcement)
Reported Feb 9, 2022
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 9, 2022
Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Celltrion USA Inc.
FDA (openFDA device enforcement)
Reported Feb 9, 2022
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
FDA (openFDA device enforcement)
Reported Feb 9, 2022
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dixi Medical USA
8 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 9, 2022
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
High riskUsing this product could cause serious injury, illness or death — stop using it now.Empowered Diagnostics LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 9, 2022
The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FEMSelect Ltd.
FDA (openFDA device enforcement)
Reported Feb 9, 2022
CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Immuno-Mycologics, Inc.
FDA (openFDA device enforcement)
Reported Feb 9, 2022
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LivaNova USA, Inc.
FDA (openFDA device enforcement)
Reported Feb 9, 2022
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Luminex Corporation
FDA (openFDA device enforcement)
Reported Feb 9, 2022
Premier Rotaclone, Rx only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 9, 2022
KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Microbiologics Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 9, 2022
Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Feb 9, 2022
eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Feb 9, 2022
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Feb 9, 2022
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
FDA (openFDA device enforcement)
Reported Feb 9, 2022
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.XTANT Medical
FDA (openFDA device enforcement)
Reported Feb 9, 2022
YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Young Dental Mfg Co. I LLC
FDA (openFDA device enforcement)
Reported Feb 2, 2022
API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomerieux Inc.
FDA (openFDA device enforcement)
Reported Feb 2, 2022
8mm FlexDex Needle Driver, Product Code FD-335 ND
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FlexDex Inc.
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.