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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.

Spectrum Central Venous Catheter Tray, Minocydine/Rifampin Antibiotic Impregnated, Double Lumen, 7.5Fr/20cm, CUDLMY751JRSCABRMFST, G13482, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

FDA Recall
Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

ConMed System 2450 Electrosurgical Generator, REF 60-2450-230, 230V-240V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.

FDA Recall
Terminated ·ConMed Electrosurgery·Product code GEI·December 27, 2010

EPIDURAL ANESTHESIA KIT/Product SKU's (Codes) ASK-03001-KC, ASK-03001-KC1 and HH-03000. Epidural anesthesia kit

FDA Recall
Terminated ·Arrow International Inc·Product code CAZ·October 29, 2010

ACCESS TRAY/Product SKU's (Codes) ASK-03000-CHUQ, ASK-03000-CHUQ1, ASK-04001-GFH, ASK-04001-SUH and ASK-04001-UHC. Access tray for epidural anesthesia kit

FDA Recall
Terminated ·Arrow International Inc·Product code CAZ·October 29, 2010

02.122.590S, 90mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

FDA Recall
Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

02.122.620, 120mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

FDA Recall
Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

ConMed System 2450 Electrosurgical Generator, REF 60-2450-100, 100 V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site

FDA Recall
Terminated ·ConMed Electrosurgery·Product code GEI·December 27, 2010

Thomas Medical Products, SafeSheath Long, (Tear-Away Sheath Introducer Set with Integral Hemostasis Valve) for use during vascular interventional procedures. Part No. FCL-051-00, Catalog No. HLS2507MCN; and Part No. FCL-051-02, Catalog No. HLS2507MCN.

FDA Recall
Terminated ·Thomas Medical Products Inc·Product code DYB·December 16, 2010

Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part number 110-0234G1 (domestic) and 110-0234G3 (international) The Orthoralix 8500 DDE Panoramic Dental X-Ray System is used as an extraoral source of x-rays for imaging of the dento-maxillofacial area.

FDA Recall
Terminated ·Gendex Dental Systems·Product code EHD·December 21, 2010

Walcott Rx Products, Surgical Division, Corneal Marking Pad, REF RX40490, Sterile. For use in ophthalmic surgery.

FDA Recall
Terminated ·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010