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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.

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)

FDA Recall
Terminated ·Howmedica Osteonics Corp.·Product code LPH·April 16, 2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile, Catalog # 504-02-68F-L, UDI (01)07613327012521(17)

FDA Recall
Terminated ·Howmedica Osteonics Corp.·Product code LPH·April 16, 2020

Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile

FDA Recall
Terminated ·Delfi Medical Innovations, Inc.·Product code KCY·April 3, 2019

REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475

FDA Recall
Terminated ·ICU Medical, Inc.·Product code FMG·October 4, 2019

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - 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

BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments.

FDA Recall
Terminated ·CME America, LLC·Product code FPA·January 14, 2020

0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DQX·December 4, 2019

Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.

FDA Recall
Open, Classified ·Ortho Development Corporation·Product code JWH·May 30, 2019

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - 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

Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830

FDA Recall
Terminated ·Product code ITJ·March 6, 2020