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 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)
Reported Feb 14, 2024
Senographe Pristina
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, SCS
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Flow-i C20 Anesthesia System, model 6677200
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge USA Sales Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Globus Medical, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Article No. NA6050411, Valiant PhD No. 1 Econo
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ivoclar Vivadent, Inc.
FDA (openFDA device enforcement)
Reported Feb 14, 2024
BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
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 14, 2024
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips North America
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
RX Series Copper (Cu) Assay Ref. Number CU2340
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
1 more product 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.