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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.

Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP.

FDA Recall
Terminated ·Integra LifeSciences Corp. d.b.a. Integra Pain Management·Product code HGB·September 4, 2013

OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 M) and KCL (300 M. 10.0ml.) PN: 50003300; Store at d - 15C. Product Usage: General Purpose Reagent for laboratory use.

FDA Recall
Terminated ·Celera Corporation·Product code LDT·July 12, 2013

INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530

FDA Recall
Terminated ·Zimmer, Inc.·Product code NDJ·October 11, 2013

U-SPECT-II/CT and VECTor/CT cabinet x-ray products. Laboratory research using small animals.

FDA Recall
Terminated ·Milabs Bv Heidelberglaan·Product code RFK·April 15, 2012

Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. Packaged in 19 packages of 100 and 6 packages of 10. Highland Metals, Inc. Wire used for orthodontic treatment to place in the brackets to shape teeth.

FDA Recall
Terminated ·Highland Metals·Product code D·July 12, 2011

OneTouch Delica Lancing Device; LifeScan Inc., Milpitas, CA Testing of Blood Glucose Levels

FDA Recall
Terminated ·Lifescan Inc·Product code F·May 27, 2011

Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-4 The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum and plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code ndr·March 31, 2011

J-Vac Bulb Suction Reservoir, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151. Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate potentially detrimental collection of certain fluids (e.g. pus, extravascular blood, bile) from wounds in body cavities and to reduce the risk of infection.

FDA Recall
Terminated ·Ethicon, Inc. US·Product code KOG·March 24, 2011

ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018455, Size 5 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves

FDA Recall
Terminated ·Ansell Healthcare Products LLC·Product code NPD·June 10, 2011

Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1

FDA Recall
Terminated ·Maquet Inc.·Product code LFQO·September 19, 2011