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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.

AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.

FDA Recall
Terminated ·Applied Medical Technology Inc·Product code KNT·January 19, 2017

Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: 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 patients pleural cavity or mediastinal area

FDA Recall
Terminated ·Atrium Medical Corporation·Product code KDQ·December 23, 2016

GYN Pack, part number AMS4013(A

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017

PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment open and facilitate discectomy

FDA Recall
Terminated ·Synthes (USA) Products LLC·Product code LXH·January 31, 2017

Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.

FDA Recall
Terminated ·Cook Inc.·Product code KGZ·February 1, 2017

Upper Torso Tray, part number PSS1554(B

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017

Ortho Minor Pack, part number AMS3710(A

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017

General Pack, part number AMS2967(A General Pack, part number AMS3239(A General Pack, part number AMS3709(B General Pack, part number AMS5341 General Pack, part number AMS5694

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017

Bayview Abdominoplasty Pack, part number 009079-1

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017

Open Procedure Pack II, part number RMS1740(A

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017