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 May 21, 2025
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Numed Inc.
FDA (openFDA device enforcement)
Reported May 21, 2025
Enterprise 1.5T, Model Number: 781145;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
13 more products in this recall
FDA (openFDA device enforcement)
Reported May 21, 2025
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Richard Wolf GmbH
FDA (openFDA device enforcement)
Reported May 21, 2025
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Vyaire Medical
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 14, 2025
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ambu Inc.
FDA (openFDA device enforcement)
Reported May 14, 2025
Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA;…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Bausch & Lomb Surgical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 14, 2025
GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Galt Medical Corporation
6 more products in this recall
FDA (openFDA device enforcement)
Reported May 14, 2025
Washer Disinfector Aquadis 56; Model Number: 56A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge Disinfection Ab
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 14, 2025
Artix MT Thrombectomy Device, REF: 32-102
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Inari Medical - Oak Canyon
FDA (openFDA device enforcement)
Reported May 14, 2025
CODMAN Disposable Perforator, 14mm. Cranial perforator.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Integra LifeSciences Corp. (NeuroSciences)
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 14, 2025
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported May 14, 2025
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.V.
FDA (openFDA device enforcement)
Reported May 14, 2025
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported May 14, 2025
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remote Diagnostic Technologies Ltd.
FDA (openFDA device enforcement)
Reported May 14, 2025
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Science & Bio Materials
FDA (openFDA device enforcement)
Reported May 14, 2025
CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported May 14, 2025
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tornier S.A.S.
FDA (openFDA device enforcement)
Reported May 14, 2025
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wandercraft Sas
FDA (openFDA device enforcement)
Reported May 7, 2025
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported May 7, 2025
Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Belmont Instrument LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 7, 2025
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 7, 2025
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Defibtech, LLC
4 more products in this recall
FDA (openFDA device enforcement)
Reported May 7, 2025
GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Medical Systems China Co., Ltd.
14 more products in this recall
FDA (openFDA device enforcement)
Reported May 7, 2025
myQA iON; Article Number: MQ10-000;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.IBA Dosimetry GmbH
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.