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 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)
Reported Jul 10, 2024
EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MicroPort Orthopedics Inc.
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nalu Medical, Inc.
FDA (openFDA device enforcement)
Reported Jul 10, 2024
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Jul 10, 2024
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Seaspine Orthopedics Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2024
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens AG/Siemens Healthcare GmbH
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2024
The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
FDA (openFDA device enforcement)
Reported Jul 10, 2024
WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.WOM World Of Medicine AG
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zyno Medical LLC
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.