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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.

Lap/Pelviscopy Pack, part number PSS3256(B

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017

Custom Venous Kit, part number TVS4024(C

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017

Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.

FDA Recall
Open, Classified ·The See Clear Company·Product code LPL·January 6, 2017

GYN Lap Pack, part number PSS2194(B

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017

Surgical Pack, part number PSS3540(A

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017

Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017

BD AffirM VPIII Microbial Identification Test

FDA Recall
Terminated ·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code MLA·August 27, 2015

cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.

FDA Recall
Terminated ·Roche Diagnostics Corporation·Product code JQP·December 27, 2016

Optilite IgG4 Kit Product Code: LK009.OPT.A

FDA Recall
Terminated ·The Binding Site Group, Ltd.·Product code CFN·December 23, 2016

Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, with in-line connector and suction control stopcock, in. Tubing, Sims and Pedi connector in bag on back of drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.

FDA Recall
Terminated ·Atrium Medical Corporation·Product code PAD·November 29, 2016