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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.

Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC, Canada H4T1A1, (514) 488-9802; INCLUDES: One (1) Radiopaque Sheath, One (1) Radiopaque Dilator; And One (1) B* x 135 cm Guidewire. Intended to allow left heart catheterization procedure to occur through the right atrium.

FDA Recall
Terminated ·Baylis Medical Corp·Product code DYB·February 8, 2010

Outlook Pump Set w/150 ml Burette w/15um Filter & Safeline Inj Site, Check Valve, 2 Safeline Inj Sites, 120 in NF3115M

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code FPA·November 24, 2009

Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, 1.2um Filter, Spin Lock Connector, 120 in US3112F

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code FPA·November 24, 2009

Outlook Pump IV Set w/Universal Spike, Check Valve, 4 Safeline Inj Sites, B/C Valve, 3 N/C Valves Stopcock, 138 in NF1501M3HP

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code FPA·November 24, 2009

Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj Sites, Spin Lock Con & Pressure Limited Check Valve, 127 in

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code FPA·November 24, 2009

ONE SOURCE PACK, Model TK2S24, EE2S048 (OUS), Manufacturer: Medtronic, Inc., Minneapolis, MN 55432-5604.

FDA Recall
Terminated ·Medtronic Inc·Product code KRI·December 14, 2009

RambaChrom VRE M/N 11600. RambaCHROM VRE is for detection of Van A/ Van B vancomycin resistant Enterococcus strains.

FDA Recall
Terminated ·Gibson Laboratories Inc·Product code JSO·December 17, 2009

Biphasic LIFEPAK 12 defibrillator / monitor.

FDA Recall
Terminated ·Physio Control, Inc.·Product code MKJ·March 31, 2009

Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-209, 10 x 60, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for palliation of malignant neoplasms in the biliary tree.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code FGE·January 28, 2010

Stryker XIA 3 Polyaxial Screw, 8.5mm x 65 mm. Catalog Number: 482318565. Not Sterile; Manufactured by Stryker Spine, SA, Cestas, France. Distributed in the USA by Stryker Spine, Allendale, NJ Intended for use in the noncervical spine.

FDA Recall
Terminated ·Stryker Spine·Product code NKB·December 30, 2009