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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.

Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.

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

Affixus Hip Fracture Nail Left 125 11 mm x 400 mm, Item Number: 814411400

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

Affixus Hip Fracture Nail Right 130 11 mm x 460 mm, Item Number: 814511460

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

Affixus Hip Fracture Nail Left 130 11 mm x 280 mm, Item Number: 814611280

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

Affixus Hip Fracture Nail Left 130 13 mm x 340 mm, Item Number: 814613340

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

VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.

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

Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number: 814511320

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

Affixus Hip Fracture Nail Left 130 9 mm x 420 mm, Item Number: 814609420

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

Affixus Hip Fracture Nail Left 130 11 mm x 460 mm, Item Number: 814611460

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

Affixus Hip Fracture Nail Right 130 13 mm x 440 mm, Item Number: 814513440

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