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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.

AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.

FDA Recall
Terminated ·Nipro Medical Corporation·Product code DQX·July 27, 2012

Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

FDA Recall
Terminated ·Clinical Diagnostic Solutions·Product code JPK·March 24, 2011

Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.

FDA Recall
Terminated ·Ventlab Corporation·Product code BTM·July 11, 2012

Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.

FDA Recall
Terminated ·GE Healthcare, LLC·Product code IZL·July 10, 2012

Ortho Clinical Diagnostics VITROS Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS 3600, VITROS 5600, and VITROS ECi/ECiQ Systems.

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code JJE·December 13, 2012

Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.

FDA Recall
Terminated ·MOOG Medical Devices Group·Product code LZH·October 12, 2012

COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.

FDA Recall
Terminated ·Roche Molecular Systems, Inc.·Product code MWA·November 28, 2012

NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

FDA Recall
Terminated ·Codman & Shurtleff, Inc.·Product code DQY·January 11, 2013

LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).

FDA Recall
Terminated ·Ansell Healthcare Products LLC·Product code HIS·January 14, 2013

NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

FDA Recall
Terminated ·Codman & Shurtleff, Inc.·Product code DQY·January 11, 2013