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 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)
Reported Feb 14, 2024
Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Balt USA, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Barco MDSC-8527 NXF, Part Number K9352421
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Barco N.V.
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
29 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
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 14, 2024
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Brasseler USA I LP
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health 200, LLC
12 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
FDA (openFDA device enforcement)
Reported Feb 14, 2024
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Sperm separation media are used to separate motile sperm from other constituents of semen.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fujifilm Irvine Scientific, Inc.
FDA (openFDA device enforcement)
Reported Feb 14, 2024
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
Moderate riskThis product could cause temporary or reversible health problems — stop using it.G & H Wire Company
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.