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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.

Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system. The stent is positioned between two radiopaque marker bands, which are located inside the balloon at the proximal and distal tapers of the balloon.

FDA Recall
Terminated ·Cook Inc.·Product code NIN·April 15, 2020

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

FDA Recall
Terminated ·Maquet Cardiovascular, LLC·Product code MAL·April 7, 2020

iChemVELOCITY Urine Chemistry System-

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code KQO·March 30, 2020

Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326

FDA Recall
Open, Classified ·Stryker Corporation·Product code MMP·January 7, 2020

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - 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 # 5203-90153, UDI # 10888857108660, Size 28x8mm, 6 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 # 5203-90139, UDI # 10888857108523, Size 24x8mm, 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

Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly

FDA Recall
Terminated ·Acutus Medical Inc·Product code DYB·February 25, 2020

Lunar iDXA bone densitometer

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

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 10888857108622, Size 28x4mm, 6 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