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 4, 2024
FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abbott Diabetes Care, Inc.
FDA (openFDA device enforcement)
Reported Sep 4, 2024
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Diagnostics Technologies AS
FDA (openFDA device enforcement)
Reported Sep 4, 2024
DR 800. Digital Radiography X-ray System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Agfa N.V.
FDA (openFDA device enforcement)
Reported Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584003;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beaver Visitec International, Inc.
158 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 4, 2024
DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Sep 4, 2024
McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cypress Medical Products LLC
FDA (openFDA device enforcement)
Reported Sep 4, 2024
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare (China) Co., Ltd.
FDA (openFDA device enforcement)
Reported Sep 4, 2024
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
FDA (openFDA device enforcement)
Reported Sep 4, 2024
Ion Endoluminal System, REF: 380748-65
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Sep 4, 2024
Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) FTMC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
54 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 4, 2024
Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Neurovision Medical Products Inc.
FDA (openFDA device enforcement)
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)
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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.