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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.

CE18TB CONT EPIDURAL TRAY, Material Number 332222 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.

FDA Recall
Terminated ·bioMerieux, Inc.·Product code LCD·August 13, 2018

Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized.

FDA Recall
Terminated ·SPS Sterilization, Inc·Product code JCT·March 7, 2018

Affixus Hip Fracture Nail Right 130 9 mm x 380 mm, Item Number: 814509380

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code HSB·July 17, 2018

ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use.

FDA Recall
Terminated ·Ventana Medical Systems Inc·Product code PPM·August 2, 2018

Affixus Hip Fracture Nail Right 130 13 mm x 460 mm, Item Number: 814513460

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code HSB·July 17, 2018

Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number: 814511360

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code HSB·July 17, 2018

iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.

FDA Recall
Terminated ·Ventana Medical Systems Inc·Product code NJT·August 2, 2018

Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number: 814511400

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code HSB·July 17, 2018

ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.

FDA Recall
Terminated ·Ventana Medical Systems Inc·Product code IBG·August 2, 2018