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 Feb 28, 2024
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
FDA (openFDA device enforcement)
Reported Feb 28, 2024
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AMD Medicom Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Baxter Exactamix Pro 1200, REF EXM12DY
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Feb 28, 2024
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health 200, LLC
9 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FUJIFILM Healthcare Americas Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Impulse Dynamics (usa) Inc.
FDA (openFDA device enforcement)
Reported Feb 28, 2024
These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Feb 28, 2024
AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MRP, LLC dba Aquabiliti
FDA (openFDA device enforcement)
Reported Feb 28, 2024
ESG PK CUTTING FORCEPS, 5MM, 33CM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ptw-Freiburg
FDA (openFDA device enforcement)
Reported Feb 28, 2024
IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Voco GmbH
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W.L. Gore & Associates, Inc.
FDA (openFDA device enforcement)
Reported Feb 28, 2024
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W&h Dentalwerk Buermoos GmbH
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
High riskUsing this product could cause serious injury, illness or death — stop using it now.Windstone Medical Packaging, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 21, 2024
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 21, 2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 21, 2024
global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
FDA (openFDA device enforcement)
Reported Feb 21, 2024
HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.HeartSine Technologies Ltd.
FDA (openFDA device enforcement)
Reported Feb 21, 2024
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 21, 2024
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics 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.