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 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)
Reported Aug 20, 2025
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spineart Sa
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Thoratec LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Trinity Biotech USA
FDA (openFDA device enforcement)
Reported Aug 20, 2025
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 13, 2025
LAPAROSCOPIC TRAY. Medical convenience kit.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AVID Medical, Inc.
23 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 13, 2025
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
High riskUsing this product could cause serious injury, illness or death — stop using it now.B Braun Medical Inc.
FDA (openFDA device enforcement)
Reported Aug 13, 2025
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Aug 13, 2025
UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 13, 2025
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton, Dickinson and Company, BD Bio Sciences
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 13, 2025
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 13, 2025
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.DRG International, 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.