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 18, 2024
Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ultradent Products, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zoe Medical Incorporated
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2024
Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
17 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2024
Power Express, REF B90918
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Biomedical GmbH
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2024
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Sep 11, 2024
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Breas Medical, Inc.
FDA (openFDA device enforcement)
Reported Sep 11, 2024
BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2024
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
FDA (openFDA device enforcement)
Reported Sep 11, 2024
Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mindray DS USA, Inc. dba Mindray North America
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2024
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model…
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 11, 2024
Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Respironics, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2024
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W L Gore & Associates, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
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)
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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.