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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.

Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code HWC·March 28, 2018

Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the ankle/foot and knee.

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code HWC·March 28, 2018

Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body

FDA Recall
Terminated ·Medtronic Sofamor Danek USA Inc·Product code KWQ·March 23, 2018

BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867

FDA Recall
Terminated ·Datascope Corporation·Product code DTN·October 19, 2017

Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)

FDA Recall
Terminated ·C.R. Bard, Inc.·Product code EZC·December 13, 2017

ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker

FDA Recall
Terminated ·Tosoh Bioscience Inc·Product code NDY·March 5, 2018

ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker

FDA Recall
Terminated ·Tosoh Bioscience Inc·Product code NIG·March 5, 2018

fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone.

FDA Recall
Terminated ·NordicNeuroLab AS Mollendalsveien 65c Bergen Norway·Product code LNH·October 28, 2017

ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone

FDA Recall
Terminated ·Tosoh Bioscience Inc·Product code JLS·March 5, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126C

FDA Recall
Terminated ·Sun Med, LLC·Product code BTM·May 24, 2018