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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.

Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer

FDA Recall
Open, Classified ·GE Healthcare, LLC·Product code KGI·December 3, 2019

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

FDA Recall
Terminated ·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90167, UDI # 10888857108806, Size 28x8mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.

FDA Recall
Terminated ·Product code HWJ·April 13, 2020

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90177, UDI # 10888857108905, Size 28x4mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.

FDA Recall
Terminated ·Product code HWJ·April 13, 2020

Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902

FDA Recall
Open, Classified ·Smith & Nephew, Inc.·Product code MBI·March 17, 2020

AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN076Z NN077Z NN078Z NN079Z NN470Z NN471Z NN472Z NN473Z NN474Z NN475Z NN476Z NN477Z NN478Z NN479Z Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free versions as well as versions with zirconium nitride multi layer.

FDA Recall
Terminated ·Aesculap Implant Systems LLC·Product code JWH·January 21, 2020

Poly G Integris H5000, System code 72246

FDA Recall
Terminated ·Philips North America, LLC·Product code IZI·December 30, 2019

Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·February 14, 2020

ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

FDA Recall
Terminated ·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code OUT·February 14, 2020

RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system

FDA Recall
Terminated ·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·February 20, 2020