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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.

BC Thrombin Reagent . Thrombin Time Test

FDA Recall
Terminated ·Dade Behring Inc. Rte 896, Glasgow Business Community·Product code GJA·July 21, 2004

Product is 1.0cc flowable paste from donor approved for distribution in Italy. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

FDA Recall
Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 90 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-104.

FDA Recall
Terminated ·Boston Scientific Corp·Product code FFL·December 20, 2005

Product is REGENAFIL Allograft Paste, Syringe, 0.5cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

FDA Recall
Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

Disney Baby Soft Cool Ring Teether Style # Y1470

FDA Recall
Terminated ·RC2 Brands Inc., The First Years·Product code KKO·January 25, 2006

LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 83 inch, with Backcheck Valve and 2 Clave Ports, Piggyback with Option-Lok; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 U.S.A.

FDA Recall
Terminated ·Hospira Inc.·Product code FPA·January 9, 2006

Product is OPTEFIL Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

FDA Recall
Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

Osteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

FDA Recall
Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

Product is Regenafil IC. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

FDA Recall
Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

Holt Probe Round Straight

FDA Recall
Terminated ·Medtronic Sofamor Danek Instrument Manufacturing·Product code HXX·December 22, 2005