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 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)
Reported Aug 6, 2025
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 6, 2025
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FUJIFILM Healthcare Americas Corporation
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hamilton Medical AG
FDA (openFDA device enforcement)
Reported Aug 6, 2025
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.HeartSine Technologies Ltd.
FDA (openFDA device enforcement)
Reported Aug 6, 2025
The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Implant Direct Sybron Manufacturing LLC
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Institut Georges Lopez
FDA (openFDA device enforcement)
Reported Aug 6, 2025
IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LTS Therapy Systems, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiopulmonary GmbH
FDA (openFDA device enforcement)
Reported Aug 6, 2025
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Aug 6, 2025
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 6, 2025
LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microvention 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.