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 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)
Reported Feb 21, 2024
Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mirion Technologies (Capintec), Inc.
FDA (openFDA device enforcement)
Reported Feb 21, 2024
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Musculoskeletal Transplant Foundation, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 21, 2024
Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NeuroLogica Corporation
FDA (openFDA device enforcement)
Reported Feb 21, 2024
Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Feb 21, 2024
Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.OriGen Biomedical, Inc.
FDA (openFDA device enforcement)
Reported Feb 21, 2024
CombiDiagnost R90 1.0 (709030)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 21, 2024
ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 21, 2024
The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quidel Corporation
FDA (openFDA device enforcement)
Reported Feb 21, 2024
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sedecal Sa
FDA (openFDA device enforcement)
Reported Feb 21, 2024
Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 21, 2024
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Wipro GE Healthcare Private Ltd.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 21, 2024
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Surgical Inc.
FDA (openFDA device enforcement)
Reported Feb 14, 2024
PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, 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.