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.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Sep 4, 2024
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ORTHOPEDIATRICS CANADA ULC dba PEGA MEDICAL
FDA (openFDA device enforcement)
Reported Sep 4, 2024
BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ronan Medical LLC
FDA (openFDA device enforcement)
Reported Sep 4, 2024
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Schiller, Ag
FDA (openFDA device enforcement)
Reported Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
27 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 4, 2024
Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling, reaming,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
9 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 4, 2024
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Treace Medical Concepts, Inc.
FDA (openFDA device enforcement)
Reported Aug 28, 2024
Alinity hq Analyzer, REF: 09P68-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
FDA (openFDA device enforcement)
Reported Aug 28, 2024
Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
35 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 28, 2024
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 28, 2024
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Mishima K.K.
FDA (openFDA device enforcement)
Reported Aug 28, 2024
BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Aug 28, 2024
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
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 28, 2024
McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien
2 more products in this recall
FDA (openFDA device enforcement)
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)
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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.