SEO landing

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.

American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usage: Neurosurgical and Nonneurosurgical Sponges

FDA Recall
Terminated ·American Surgical Company·Product code GDY·March 31, 2016

American Surgical Ultracot 30 mm x 70 mm Ref Number: 23-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

FDA Recall
Terminated ·American Surgical Company·Product code GDY·March 31, 2016

Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.

FDA Recall
Terminated ·Volcano Corporation·Product code OBJ·April 25, 2016

Various trauma and sports medicine instruments and implants. Arthroscope.

FDA Recall
Terminated ·Biomet, Inc.·Product code HRX·April 1, 2016

SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted in the patient during a surgical procedure.

FDA Recall
Terminated ·Intuitive Surgical, Inc.·Product code GCY·May 9, 2016

PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.

FDA Recall
Terminated ·Biomet, Inc.·Product code FMF·April 11, 2016

American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neurosurgical and Nonneurosurgical Sponges

FDA Recall
Terminated ·American Surgical Company·Product code HBA·March 31, 2016

Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Recall
Terminated ·Dexcom Inc·Product code MDS·February 23, 2016

Catalog Number: 9001298 PREMIUM ARTHROSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·January 7, 2016

RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver

FDA Recall
Terminated ·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWP·March 18, 2016