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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.

Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.

FDA Recall
Terminated ·Soft Computer Consultants, Inc.·Product code NSX·October 6, 2016

Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi Modular P Product Code LK009.H/LK001.H This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents

FDA Recall
Terminated ·The Binding Site Group, Ltd.·Product code CFN·September 11, 2014

Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery drain with in-line connector 3652-100 Oasis Double Blood Recovery drain with in-line connectors - 2 patient lines connected by one Y connector Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.

FDA Recall
Terminated ·Atrium Medical Corporation·Product code PAD·November 29, 2016

Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit

FDA Recall
Terminated ·Baxter Healthcare Corporation·Product code KDI·January 4, 2017

Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.

FDA Recall
Terminated ·Merge Healthcare, Inc.·Product code HKI·December 9, 2016

Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corporation·Product code MWS·August 20, 2014

OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary calculi and soft tissue applications including incision/excision, ablation, and coagulation

FDA Recall
Terminated ·Cook Inc.·Product code GEX·May 3, 2017

1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit

FDA Recall
Terminated ·Arrow International Inc·Product code DYB·May 9, 2017

TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32CM TIBIAL I/M NAIL 14MMDX34CM TIBIAL I/M NAIL 15MMDX34CM TIBIAL I/M NAIL 14MMDX36CM TIBIAL I/M NAIL 15MMDX36CM TIBIAL I/M NAIL 14MMDX38CM TIBIAL I/M NAIL 15MMDX38CM TIBIAL I/M NAIL 13MMDX40CM TIBIAL I/M NAIL 14MMDX40CM TIBIAL I/M NAIL 15MMDX40CM TIBIAL I/M NAIL 13MMDX42CM TIBIAL I/M NAIL 14MMDX42CM TIBIAL I/M NAIL 15MMDX42CM TIBIAL I/M NAIL 11MMDX44CM TIBIAL I/M NAIL 13MMDX44CM TIBIAL I/M NAIL 14MMDX44CM TIBIAL I/M NAIL 11MMDX46CM TIBIAL I/M NAIL 12MMDX46CM TIBIAL I/M NAIL 13MMDX46CM

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code HSB·April 28, 2017

Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.

FDA Recall
Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code GCJ·May 4, 2017