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 17, 2024
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2024
GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Vingmed Ultrasound As
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2024
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge USA Sales Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2024
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
FDA (openFDA device enforcement)
Reported Jul 17, 2024
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2024
Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MICROspecialties, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2024
24K Premium Lense, Distributed by Updream Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ontact Inc.
FDA (openFDA device enforcement)
Reported Jul 17, 2024
Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pivotal Health Solutions, Inc.
FDA (openFDA device enforcement)
Reported Jul 17, 2024
9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preat Corp.
FDA (openFDA device enforcement)
Reported Jul 17, 2024
Pink Luminous Breast, Breast transilluminator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Silkprousa LLC
FDA (openFDA device enforcement)
Reported Jul 17, 2024
Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Svs LLC
FDA (openFDA device enforcement)
Reported Jul 17, 2024
BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
High riskUsing this product could cause serious injury, illness or death — stop using it now.Synergetics Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2024
ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zoll Medical Corporation
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Medical
FDA (openFDA device enforcement)
Reported Jul 10, 2024
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
FDA (openFDA device enforcement)
Reported Jul 10, 2024
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Applied Medical Technology Inc.
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It…
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 Jul 10, 2024
BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
FDA (openFDA device enforcement)
Reported Jul 10, 2024
First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.First Source Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Information Technologies Inc.
FDA (openFDA device enforcement)
Reported Jul 10, 2024
HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Horiba Instruments Incorporated
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Megadyne Medical Products, Inc.
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.