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 Aug 28, 2024
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Inari Medical - Oak Canyon
FDA (openFDA device enforcement)
Reported Aug 28, 2024
Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intrinsic Therapeutics, Inc.
FDA (openFDA device enforcement)
Reported Aug 28, 2024
IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ion Beam Applications S.A.
FDA (openFDA device enforcement)
Reported Aug 28, 2024
LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
20 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 28, 2024
C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microtek Medical Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 28, 2024
GM60A. Digital Diagnostic Mobile X-Ray System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NeuroLogica Corporation
FDA (openFDA device enforcement)
Reported Aug 28, 2024
The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Aug 28, 2024
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
FDA (openFDA device enforcement)
Reported Aug 28, 2024
Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preat Corp.
FDA (openFDA device enforcement)
Reported Aug 28, 2024
Regard Kit containing the Microtek decanter
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
FDA (openFDA device enforcement)
Reported Aug 28, 2024
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
FDA (openFDA device enforcement)
Reported Aug 28, 2024
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ventana Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Aug 21, 2024
L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Argon Medical Devices, Inc.
FDA (openFDA device enforcement)
Reported Aug 21, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 21, 2024
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Aug 21, 2024
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biointellisense Inc.
FDA (openFDA device enforcement)
Reported Aug 21, 2024
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Neuromodulation Corporation
FDA (openFDA device enforcement)
Reported Aug 21, 2024
Cepheid, Sample Collection Device, Part: 900-0370
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cepheid
FDA (openFDA device enforcement)
Reported Aug 21, 2024
RMU-2000 Automated Chest Compression Device
High riskUsing this product could cause serious injury, illness or death — stop using it now.Defibtech, LLC
FDA (openFDA device enforcement)
Reported Aug 21, 2024
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DKK Dai-Ichi Shomei Co., Ltd.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 21, 2024
Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.DRG International, Inc.
FDA (openFDA device enforcement)
Reported Aug 21, 2024
Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Eye Comfort Care LLC
FDA (openFDA device enforcement)
Reported Aug 21, 2024
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ICU Medical Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
22 more products in this recall
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.