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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.

Major Lithotomy Pack, kit number 002641-5 and 002641-6 convenience custom kits used for general surgery in hospital operating room

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015

Keystone Dental PrimaConnex Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations and terminal or inter-mediate abutment support for fixed bridgework

FDA Recall
Terminated ·Keystone Dental Inc·Product code DZE·September 15, 2016

Open Procedure Pack II, Kit number RMS1740(A convenience custom kits used for general surgery in hospital operating room

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015

CORE Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures

FDA Recall
Terminated ·ConMed Corporation·Product code GBW·June 27, 2016

Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015

General Plastic Pack, Kit number PSS2432, PSS2432(A, PSS2717, PSS2717(A, and PSS2717(B. convenience custom kits used for general surgery in hospital operating room

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015

ENT Tray, Kit number AMS1195(A convenience custom kits used for general surgery in hospital operating room

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015

Total Hip Pack, Kit number PSS2956 convenience custom kits used for general surgery in hospital operating room

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015

Major Pack, Kit Number PSS3516 and PSS3516(A convenience custom kits used for general surgery in hospital operating room

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015

Ortho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used for general surgery in hospital operating room

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015