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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.

Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: 0386-0009-75; Manufactured by Gebauer Company, Cleveland, Ohio

FDA Recall
Terminated ·Gebauer Company·Product code LFD·January 19, 2007

Symbia S Series SPECT (Single-Photon Emission Computed Tomography) System with a Pinhole Collimator; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203 USA; part number 08717741

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·January 30, 2007

Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S.

FDA Recall
Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S.

FDA Recall
Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

Mobilett XP, mobile X-ray system, Model number 1818454

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IZL·March 21, 2007

535D-X CF Continuous Flow Cylinder

FDA Recall
Terminated ·Sunrise Medical·Product code NFB·January 24, 2007

OEC 9800 Fluoroscopic X-ray System, Model Number A349855, GE Healthcare, Surgery.

FDA Recall
Terminated ·GE OEC Medical Systems, Inc·Product code JAA·February 9, 2007

ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version 21.0; for use on the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list number 06E58-21

FDA Recall
Terminated ·Abbott Laboratories MPG·Product code JJI·January 2, 2007

Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·August 1, 2005

Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·August 1, 2005