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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.

Peripherally Inserted Central Venous Catheter Tray Silicone, CPICSY401HOPKINS0911 00, G13169, 4.0 Fr/60cm, Sterile, Cook Incorporated, 750 Daniels Way, Bloomington, IN 47404 , USA

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

02.122.595S, 95mm 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

Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries.

FDA Recall
Terminated ·Stryker Instruments Division of Stryker Corporation·Product code HBE·November 30, 2010

Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

FDA Recall
Terminated ·Elekta, Inc.·Product code IYE·January 5, 2011

02.122.591S, 90mm Spiral Blade, 14mm, Left-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

02.122.621S, 120mm Spiral Blade, 14mm, Left-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

02.122.600S, 100mm 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

PEDIATRIC JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04150-E Pediatric jugular puncture kit

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

Applied Medical's LAP CHOLE KIT ; Model Number: K0492 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

FDA Recall
Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·September 10, 2010

Precedence Imaging System; 6 Slice 3/8; 6 slice 5/8 Philips Medical Systems An imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system.

FDA Recall
Terminated ·Philips Medical Systems·Product code JAK·December 28, 2010