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 Aug 27, 2025
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dynex Technologies, Inc.
FDA (openFDA device enforcement)
Reported Aug 27, 2025
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hamilton Medical AG
FDA (openFDA device enforcement)
Reported Aug 27, 2025
Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Immunotech A.S.
FDA (openFDA device enforcement)
Reported Aug 27, 2025
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lumenis, Ltd.
FDA (openFDA device enforcement)
Reported Aug 27, 2025
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mckesson Medical-Surgical Inc. Corporate Office
FDA (openFDA device enforcement)
Reported Aug 27, 2025
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 27, 2025
VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Aug 27, 2025
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pentax
FDA (openFDA device enforcement)
Reported Aug 27, 2025
Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spiggle & Theis Mt GmbH
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Ambu Inc.
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefree Surgical Specialties
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Diversatek Healthcare
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number:…
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)
Reported Aug 20, 2025
GE Signa Artist, Nuclear Magnetic Resonance Imaging System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
21 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Insightra Medical Inc.
FDA (openFDA device enforcement)
Reported Aug 20, 2025
HemosIL LMW Heparin Controls; Part Number: 0020300200;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
FDA (openFDA device enforcement)
Reported Aug 20, 2025
High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 20, 2025
DreamStation Auto CPAP. Non-Continuous Ventilator.
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 Aug 20, 2025
3mensio Workstation (Vascular Fenestrated) software
Moderate riskThis product could cause temporary or reversible health problems — stop using it.PIE Medical Imaging B.V.
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spark Biomedical 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.