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 Sep 13, 2023
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
FDA (openFDA device enforcement)
Reported Sep 6, 2023
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accuray Incorporated
FDA (openFDA device enforcement)
Reported Sep 6, 2023
LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
FDA (openFDA device enforcement)
Reported Sep 6, 2023
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Sep 6, 2023
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardiac Assist, Inc.
FDA (openFDA device enforcement)
Reported Sep 6, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datascope Corp.
9 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 6, 2023
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Edwards Lifesciences, LLC
FDA (openFDA device enforcement)
Reported Sep 6, 2023
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
FDA (openFDA device enforcement)
Reported Sep 6, 2023
Oculus Pentacam AXL Wave, Ref 70020, CE 0123
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oculus Optikgeraete GmbH
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 6, 2023
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
16 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 6, 2023
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
FDA (openFDA device enforcement)
Reported Sep 6, 2023
RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
FDA (openFDA device enforcement)
Reported Sep 6, 2023
PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Reichert, Inc.
FDA (openFDA device enforcement)
Reported Sep 6, 2023
epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 6, 2023
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 6, 2023
GS70 Salus Surgical Table, Product Code 18-070-70
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Skytron, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 6, 2023
PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
FDA (openFDA device enforcement)
Reported Sep 6, 2023
SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
FDA (openFDA device enforcement)
Reported Sep 6, 2023
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
FDA (openFDA device enforcement)
Reported Aug 30, 2023
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 30, 2023
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 30, 2023
Carina Sub-Acute Care Ventilator
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
FDA (openFDA device enforcement)
Reported Aug 30, 2023
Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical Inc.
FDA (openFDA device enforcement)
Reported Aug 30, 2023
DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s):…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Invacare Corporation
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.