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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.

Merit Inflation Syringe Kit. Catalog Number KOS-02857

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code MAV·August 25, 2016

Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain

FDA Recall
Terminated ·Ivoclar Vivadent, Inc.·Product code EIH·May 27, 2016

MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DYB·September 8, 2016

IgE Calibrator Series

FDA Recall
Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code DGC·September 7, 2016

ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.

FDA Recall
Terminated ·LDR Spine USA, Inc.·Product code LXH·August 29, 2016

Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in hospital operating room

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015

GYN Lap Pack, Kit number PSS2194(B convenience custom kits used for general surgery in hospital operating room

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015

Laparoscopy Pack, Kit number AMS2537 and AMS2537(A convenience custom kits used for general surgery in hospital operating room

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015

VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier Nos. 10758750008889 and 10758750004768, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code CDT·August 11, 2016

Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 453564262571 453564262591 453564615351 453564615371 453564467761 (Korea) 453564467781 (Korea) 453564451791 (Japan, Taiwan, Indonesia) 453564451811 (Japan, Taiwan, Indonesia) 453564467821 (Mexico) 453564467841 (China) 453564467861 (China) Worldwide SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals

FDA Recall
Terminated ·Philips Electronics North America Corporation·Product code MHX·September 19, 2016