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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.

SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910

FDA Recall
Open, Classified ·Howmedica Osteonics Corp.·Product code JWH·December 1, 2023

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524

FDA Recall
Open, Classified ·Howmedica Osteonics Corp.·Product code JWH·December 1, 2023

HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J

FDA Recall
Open, Classified ·Howmedica Osteonics Corp.·Product code JWH·December 1, 2023

Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.

FDA Recall
Open, Classified ·Philips North America·Product code LNI·January 3, 2024

TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324

FDA Recall
Open, Classified ·Howmedica Osteonics Corp.·Product code JWH·December 1, 2023

smiths medical Medfusion Model 3500 Syringe pump

FDA Recall
Open, Classified ·Smiths Medical ASD Inc.·Product code FRN·December 19, 2023

LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028

FDA Recall
Open, Classified ·Howmedica Osteonics Corp.·Product code JWH·December 1, 2023

Achieva 1.5T Initial system. Model (REF) Numbers 781178.

FDA Recall
Open, Classified ·Philips North America·Product code LNI·January 3, 2024

MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OIB·December 21, 2023

Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code FMF·December 28, 2023