SEO landing

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.

Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The Azurion series (within the limits of the used Operating Room table) are intended for use to perform: Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: . The Azurion series can be used in a hybrid Operating Room. The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.

FDA Recall
Terminated ·Philips North America, LLC·Product code OWB·July 16, 2019

The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-contained unit that consists of a light source unit and a single use catheter. The light source contains a microprocessor with software to provide safety features and a user-friendly interface. The laser operates by producing a high current discharge within a chamber that is filled with rare gases and halogen. The discharge produces pulses of UV light, which is amplified by reflecting the energy within the resonating chamber many times. The output is directed to the desired target location by the catheter. A footswitch connected to the light source controls the laser action.

FDA Recall
Terminated ·Ra Medical Systems Inc·Product code PDU·February 15, 2018

VITROS 250AT Chemistry System, clinical chemistry analyzer

FDA Recall
Terminated ·Ortho Clinical Diagnostics·Product code JJE·July 8, 2019

GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397500, 14.5F, straight, 50cm length, BARD, UDI: 00801741012358

FDA Recall
Terminated ·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019

GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397310, 14.5F, straight, 31cm length, BARD, UDI: 00801741012327

FDA Recall
Terminated ·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019

BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213

FDA Recall
Terminated ·Becton Dickinson & Co.·Product code JTC·July 26, 2019

Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933

FDA Recall
Terminated ·CareFusion 303, Inc.·Product code CCK·July 1, 2019

Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

FDA Recall
Terminated ·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019

GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397190, 14.5F, straight, 19cm length, BARD, UDI: 00801741012297

FDA Recall
Terminated ·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019

K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine.

FDA Recall
Terminated ·BioPro, Inc.·Product code NBH·June 25, 2019