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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.

Shower Seat, Non-rotating, Catalog number 727152000

FDA Recall
Terminated ·Nutech Manufacturing Corp·Product code IKX·July 9, 2009

Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only. Protg EverFlex" Self-Expanding Peripheral Stent System (for Outside United States distribution). 6 x 100mm, Model Number PRP35-06-100-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only. In the United States, the stent is intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the United States, it is intended indicated for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, superficial femoral, proximal popliteal, or subclavian arteries.

FDA Recall
Terminated ·Product code FGE·November 6, 2009

Merit Medical Systems, Inc. Connection tubes label reading in part: CONNECTING TUBE W/ STOPCOCK 12" CATALOG NUMBER K10-04131 LOT F720653 Connection tubing can be used with any drainage catheter and drainage bag

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code DQO·September 29, 2009

Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300. Distributed by Medtronic Xomed, Inc. Jacksonville, Florida 32216 U.S.A. The Repose G@ Bone Screw System is composed of the Repose Bone Screw (a miniature, self-tapping screw attached to polypropylene suture), the Repose Bone Screw Inserter (a battery operated, disposable device that deploys the screw), the Repose Suture Passer, and the Repose Tongue Retractor.

FDA Recall
Terminated ·Medtronic Xomed, Inc.·Product code LRK·July 27, 2009

Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden

FDA Recall
Terminated ·MAQUET Inc.·Product code CBK·November 17, 2009

SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the administration of supplemental oxygen.

FDA Recall
Terminated ·Sequal Technologies Inc·Product code CAW·October 1, 2009

AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)

FDA Recall
Terminated ·Abbott Medical Optics Inc (AMO)·Product code HQL·November 11, 2009

Paramed Polypropylene evacuation sled for non-ambulatory patients. Hand-carried stretcher. Product 11-778-01.

FDA Recall
Terminated ·Paramed Systems·Product code FPP·October 29, 2008

9200 Advisor Vital Signs Monitor uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 Main St., Westfield, PA 16950).

FDA Recall
Terminated ·Smiths Medical PM, Inc. N7·Product code CCK·January 15, 2010

Mistique Infusion Catheter, K12-MIC13510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010