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 Jan 15, 2025
Dialyzer Optiflux 160NRe
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2025
VACUETTE SAFELINK, REF: 450210
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Greiner Bio-One GmbH
FDA (openFDA device enforcement)
Reported Jan 15, 2025
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ids Ltd.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
High riskUsing this product could cause serious injury, illness or death — stop using it now.Jiangsu Jumao X-Care Medical Equipment Co. Ltd.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Maquet Cardiovascular, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2025
Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nipro Renal Soultions USA, Corporation
FDA (openFDA device enforcement)
Reported Jan 15, 2025
The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Qualigen Inc.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spacelabs Healthcare, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2025
100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
FDA (openFDA device enforcement)
Reported Jan 8, 2025
3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.3M Unitek Corporation
FDA (openFDA device enforcement)
Reported Jan 8, 2025
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
FDA (openFDA device enforcement)
Reported Jan 8, 2025
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
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 Jan 8, 2025
Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carwild Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 8, 2025
SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Med Michigan Holding LLC
FDA (openFDA device enforcement)
Reported Jan 8, 2025
Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
17 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 8, 2025
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2025
Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.3M Company - Health Care Business
FDA (openFDA device enforcement)
Reported Jan 1, 2025
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Medical
FDA (openFDA device enforcement)
Reported Jan 1, 2025
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Vascular Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2025
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Jan 1, 2025
FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton, Dickinson and Company, BD Bio Sciences
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2025
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Braemar Manufacturing, LLC
FDA (openFDA device enforcement)
Reported Jan 1, 2025
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
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.