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 Jul 6, 2022
QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microgenics Corporation
FDA (openFDA device enforcement)
Reported Jul 6, 2022
SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model #…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Jul 6, 2022
RayStation 11B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
FDA (openFDA device enforcement)
Reported Jul 6, 2022
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
FDA (openFDA device enforcement)
Reported Jul 6, 2022
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Jul 6, 2022
Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Skytron, Div. The KMW Group, Inc.
FDA (openFDA device enforcement)
Reported Jul 6, 2022
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Volcano Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 6, 2022
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
FDA (openFDA device enforcement)
Reported Jun 29, 2022
Alcon Clareon IOL with AutonoMe Delivery System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Laboratories Ireland, Ltd.
FDA (openFDA device enforcement)
Reported Jun 29, 2022
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
FDA (openFDA device enforcement)
Reported Jun 29, 2022
BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beaver Visitec International, Inc.
FDA (openFDA device enforcement)
Reported Jun 29, 2022
CardioTek EP-TRACER Software V2.x.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CardioTek BV
FDA (openFDA device enforcement)
Reported Jun 29, 2022
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Getinge USA Sales Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 29, 2022
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
FDA (openFDA device enforcement)
Reported Jun 29, 2022
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc.
FDA (openFDA device enforcement)
Reported Jun 29, 2022
Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.New Standard Device Inc.
FDA (openFDA device enforcement)
Reported Jun 29, 2022
Colonovideoscope Model CF-H180AL
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 Jun 29, 2022
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 22, 2022
Drager SafeStar 55, Catalog No. MP01790
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
FDA (openFDA device enforcement)
Reported Jun 22, 2022
CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
FDA (openFDA device enforcement)
Reported Jun 22, 2022
illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Illumina, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 22, 2022
Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 22, 2022
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Micro Therapeutics, Inc.
FDA (openFDA device enforcement)
Reported Jun 22, 2022
Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
2 more products 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.