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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.

VER2 HANDLE, PIN REWORK, LT Nonsterile

FDA Recall
Terminated ·Zimmer, Inc.·Product code LXH·July 23, 2014

VI DBL OFFST W/ LRG STPL, LT Nonsterile

FDA Recall
Terminated ·Zimmer, Inc.·Product code LXH·July 23, 2014

Double Offset Rasp Handle, Left Hand Nonsterile

FDA Recall
Terminated ·Zimmer, Inc.·Product code LXH·July 23, 2014

VER2 D8L OFFSET RASP HANDLE, RT Nonsterile

FDA Recall
Terminated ·Zimmer, Inc.·Product code LXH·July 23, 2014

BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.

FDA Recall
Terminated ·BD Biosciences, Systems & Reagents·Product code GKZ·July 18, 2014

Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length. Product Usage: The Moore Hip Prosthesis is a femoral him stem that can be used where there is roentgenogrpahic evidence of a satisfactory actabulum and sufficient bone in the femoral neck to seat the prosthesis with or without bone cement.

FDA Recall
Terminated ·Zimmer, Inc.·Product code JDG·July 1, 2014

Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.

FDA Recall
Terminated ·Novocol, Inc.·Product code KLE·July 16, 2014

Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.

FDA Recall
Terminated ·Zimmer, Inc.·Product code HRS·June 10, 2014

Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.

FDA Recall
Terminated ·Carestream Health Inc.·Product code IWZ·July 2, 2014

Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones.

FDA Recall
Terminated ·Small Bone Innovations·Product code HWC·May 19, 2014