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 Jul 28, 2021
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
21 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 28, 2021
(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 28, 2021
Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Gentherm Medical, LLC
FDA (openFDA device enforcement)
Reported Jul 28, 2021
ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mckesson Medical-Surgical Inc. Corporate Office
FDA (openFDA device enforcement)
Reported Jul 28, 2021
AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mediana Co., Ltd.
FDA (openFDA device enforcement)
Reported Jul 28, 2021
Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries Inc.
FDA (openFDA device enforcement)
Reported Jul 28, 2021
Medtronic Reveal LINQ LNQ11 / PA96000
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 Jul 28, 2021
3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Mindray DS USA, Inc. dba Mindray North America
FDA (openFDA device enforcement)
Reported Jul 28, 2021
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
FDA (openFDA device enforcement)
Reported Jul 28, 2021
Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Respironics California, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 28, 2021
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Soft Computer Consultants, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 28, 2021
Stimulen Collagen Moisturizing Lotion, ST9555B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Southwest Technologies Inc.
FDA (openFDA device enforcement)
Reported Jul 28, 2021
Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Spine
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 21, 2021
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Arrow International Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 21, 2021
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Axonics Modulation Technologies, Inc.
FDA (openFDA device enforcement)
Reported Jul 21, 2021
EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Jul 21, 2021
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 21, 2021
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C-Rad Positioning Ab
FDA (openFDA device enforcement)
Reported Jul 21, 2021
Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: use as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 21, 2021
Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cordis Corporation
FDA (openFDA device enforcement)
Reported Jul 21, 2021
SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
13 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 21, 2021
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Heartware, Inc.
FDA (openFDA device enforcement)
Reported Jul 21, 2021
EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Implantcast GmbH
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.