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 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)
Reported May 7, 2025
HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Leica Biosystems Melbourne Pty Ltd.
FDA (openFDA device enforcement)
Reported May 7, 2025
Medline Sterile Water, USP, 100mL, REF RDI30295
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
9 more products in this recall
FDA (openFDA device enforcement)
Reported May 7, 2025
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported May 7, 2025
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported May 7, 2025
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 7, 2025
Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spectrum Medical Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 7, 2025
The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Trimble Ab
FDA (openFDA device enforcement)
Reported May 7, 2025
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2025
The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Molecular, Inc.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott
1 more product 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.