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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.

AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 14 cm, Diameter: 11 mm, Product Number 72401450

FDA Recall
Terminated ·American Medical Systems·Product code JCW·April 29, 2004

Myeloperoxidase (MPO) ELISA kit ; BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

FDA Recall
Terminated ·BioCheck Inc·Product code NTV·December 22, 2010

Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.

FDA Recall
Terminated ·Nipro Medical Corporation·Product code LLB·August 13, 2015

rHead Recon Stem Implant non-coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

FDA Recall
Terminated ·Howmedica Osteonics Corp.·Product code LTF·October 24, 2017

radial head implant #3 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

FDA Recall
Terminated ·Howmedica Osteonics Corp.·Product code LTF·October 24, 2017

#2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

FDA Recall
Terminated ·Howmedica Osteonics Corp.·Product code LTF·October 24, 2017

#4 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

FDA Recall
Terminated ·Howmedica Osteonics Corp.·Product code LTF·October 24, 2017

radial stem implant #1 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

FDA Recall
Terminated ·Howmedica Osteonics Corp.·Product code LTF·October 24, 2017

FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only

FDA Recall
Terminated ·Biofire Defense·Product code PRD·August 20, 2019

Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830

FDA Recall
Open, Classified ·Rebiscan, Inc.·Product code PMW·October 3, 2022