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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.

CORDIS "Dura Star" 2.25 x 25 Dilatation Catheter, Catalog # 70125225, Distributed by Cordis Corporation, Miami Lakes, FL 33014

FDA Recall
Terminated ·Cordis Corporation·Product code LOX·January 14, 2008

Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca 94089

FDA Recall
Terminated ·Kyphon Inc·Product code BSP·April 25, 2006

CORDIS "Fire Star" 3.50 x 10 Dilatation Catheter, Catalog # 80110350, Distributed by Cordis Corporation, Miami Lakes, FL 33014

FDA Recall
Terminated ·Cordis Corporation·Product code LOX·January 14, 2008

Centurion Healthcare Products Laceration Tray, sterile; (Reorder SUT8805A) Tri-State Hospital Supply Co., Howell, MI 48844. The primary kit is labeled as containing 1 needle, 21G x 1-1/2", among other components, however some kits may contain a 21Gx1" needle. The label on the Kendall Monoject Magellan 21G Safety Needle itself is the correct size.

FDA Recall
Terminated ·Tri-State Hospital Supply Corporation·Product code LRP·October 26, 2007

MicroBiologics; P. vulgaris, DuoPacksl Product Catalog Number: 0691P; ARCC 0427; Exp 2008-9; MicroBiologics, St. Cloud, MN 56303. (Proteus vulgaris, Kwik-Stick, Cat. No. 0691P)

FDA Recall
Terminated ·Microbiologics Inc·Product code JTR·October 12, 2007

Arrow ARROWg+ard Super Arrow-Flex Percutaneous Sheath Introducers

FDA Recall
Terminated ·Arrow International Inc·Product code DYB·February 11, 2009

Arrow Multi-Lumen CVC w/ BlueFlex Tip (Central Venous Catheter)

FDA Recall
Terminated ·Arrow International Inc·Product code DQY·February 11, 2009

Philips Avalon Fetal Monitor FM30; Model Number: M2703A.

FDA Recall
Terminated ·Philips Healthcare Inc.·Product code HGM·May 12, 2009

Stryker Xia Dual Anterior Staple; Non Sterile; Catalog number 03820115; Manufactured by Stryker Spine SAS, Cestas, France; Distributed by Howmedica Osteonics Corp, Mahwah, NJ 07430 Single use device sterilized prior to use. For anterior/anterolateral and posterior noncervical pedicle and non-pedicle fixation for the following: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, psudoartrosis, and failed previous fusion.

FDA Recall
Terminated ·Stryker Spine·Product code NKB·April 12, 2007

Siemens Medical Solutions E.CAM Patient Handling System (PHS) Field of View (FOV) indicator bars; a component of the E.CAM Emission Computed Tomography System; part number 43 66 618 (right) and 43 81 088 (left).

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·December 18, 2008