SEO landing

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.

STERIS 4085, 5085 & 5085SRT Surgical Tables

FDA Recall
Terminated ·Steris Corporation·Product code FQO·May 14, 2010

Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-220, UPN Product No. M001452200, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

FDA Recall
Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

Coseal Surgical Sealant 2mL, Product Codes: 934070 & 934073. Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.

FDA Recall
Terminated ·Baxter Bioscience·Product code NBE·January 14, 2010

Stryker 9 MM AVS TL Trial Spacer; Catalog number: 48389409. Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401. Intended for use in the thoraco-lumbar spine.

FDA Recall
Terminated ·Stryker Spine·Product code MDM·May 13, 2010

Hemashield Gold Woven and Knitted Double Vascular Grafts.

FDA Recall
Terminated ·Maquet Cardiovascular, LLC·Product code MAL·May 24, 2010

Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transistor liquid crystal display (TFT-LCD). The PNs are 010-1619-00 and 010-1655-00, Models 94260-19 and 94256.

FDA Recall
Terminated ·Spacelabs Healthcare, Llc·Product code DXJ·March 20, 2009

1.5 mm Inion CPS Baby, 4 hole plate, REF PLT-1000, sterile, Manufacturer, INION Oy, Finland.

FDA Recall
Terminated ·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010

NexGen Complete Knee Solution Rotating Hinge Knee tibial broach impactor, Catalog # 00-5881-080-00, Zimmer Inc., Warsaw, IN.

FDA Recall
Terminated ·Zimmer Inc.·Product code LXH·April 16, 2010

1.5 mm Inion CPS Baby , X- plate 7 holes, REF PLT-1003, sterile, Manufacturer, INION Oy, Finland.

FDA Recall
Terminated ·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010

2.0 mm Inion CPS, 2.0 x 5 mm screw, REF SCR-1224, sterile, Manufacturer, INION Oy, Finland.

FDA Recall
Terminated ·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010