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 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)
Reported Aug 13, 2025
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2),…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Flexicare Medical (Dongguan) Ltd.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 13, 2025
Plum Duo Infusion System, List Number: 400020401
High riskUsing this product could cause serious injury, illness or death — stop using it now.ICU Medical, Inc.
FDA (openFDA device enforcement)
Reported Aug 13, 2025
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intersurgical Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 13, 2025
DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 &…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nuclein LLC
FDA (openFDA device enforcement)
Reported Aug 13, 2025
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems (Cleveland) Inc.
FDA (openFDA device enforcement)
Reported Aug 13, 2025
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics Inc.
FDA (openFDA device enforcement)
Reported Aug 13, 2025
Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
FDA (openFDA device enforcement)
Reported Aug 6, 2025
3M Ranger Irrigation Fluid Warming Set, REF 24750
Moderate riskThis product could cause temporary or reversible health problems — stop using it.3M Company
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Molding Equipment. WCM series. Model WCM-330GL-i
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Apic Yamada America
FDA (openFDA device enforcement)
Reported Aug 6, 2025
BostonSight SCLERAL Lens
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Foundation For Sight
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Capnia Inc.
FDA (openFDA device enforcement)
Reported Aug 6, 2025
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger, Inc.
3 more products 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.