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FDA Medical Device Recalls

View 10000 FDA Medical Device Recalls on BEUDAMED, the Better Database on Medical Devices. This searchable listing aggregates recall notices issued by the U.S. Food and Drug Administration for devices removed, corrected, or returned due to safety, labeling, or performance concerns. Each record summarizes the recall reason, affected models and lots, recall class, and recommended actions for patients and providers.

Searchable filters help stakeholders identify affected manufacturers, device models, and recall classes (Class I–III) and review timelines and remediation steps. Healthcare providers and purchasers can use these records to verify whether inventory is affected and to implement recommended corrections, returns, or patient notifications.

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FDA Recall
Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code LLZ·January 10, 2024

The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The outer diameter surface of the catheter is hydrophilically coated to increase lubricity. The AOMC is designed to facilitate catheter retrieval in the event the catheter becomes entrapped within the vasculature. The distal section of the catheter incorporates a detachment zone that allows detachment of the distal tip when the force required to extract the catheter exceeds the force to detach the tip. The catheter has two radiopaque marker bands to visualize the position of the catheter and the detach zone area, one proximal to the detach zone and one at the distal end of the catheter.

FDA Recall
Open, Classified ·Micro Therapeutics, Inc.·Product code MFE·January 11, 2024

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FDA Recall
Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code LLZ·January 10, 2024

X3 TRIATHLON CS INSERT NO 3 10 MM

FDA Recall
Open, Classified ·Howmedica Osteonics Corp.·Product code MBH·February 6, 2024

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL

FDA Recall
Open, Classified ·Product code GCJ·February 28, 2024

Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code QTC·March 5, 2024

Colonoscope, Model Number PCF-H190DL.

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code NWB·January 11, 2024

Colonoscope, Model Number CF-HQ190L.

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code FDF·January 11, 2024

Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

FDA Recall
Open, Classified ·Integra LifeSciences Corp.·Product code HBG·January 19, 2024

13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S

FDA Recall
Open, Classified ·Synthes (USA) Products LLC·Product code HSB·January 24, 2024