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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.

ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-145.

FDA Recall
Terminated ·Warsaw Orthopedic, Inc.·Product code HWC·January 4, 2005

Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) Model Number 2005-001

FDA Recall
Terminated ·Harvard Clinical Technology·Product code MEA·November 3, 2004

Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NJ4303 (Reorder No. 21-0426-01) described as 110 inch length/279 cm, 16.5ml priming volume, 20 drops/ml, 3 Luer-Activated Valve injenction Sites Burette set.

FDA Recall
Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

Equator Forced Air Convective Warming System, Reference Number EQ 5000

FDA Recall
Terminated ·Smiths Medical ASD, Inc.·Product code DWJ·December 15, 2004

VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc., a Johnson & Johnson Company, Somerville, NJ 08876. The product subject of this recall is the connector cable which goes between the electrosurgical generator and the elctrode used for surgery. Specifically, the recall focuses on the hand grip on the electrode, formed by overmolding a polymer onto the cable, which deforms upon sterilization.

FDA Recall
Terminated ·Ethicon, Inc US·Product code HIH·December 16, 2004

Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=112mm, C=82mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-82.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·December 20, 2004

Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number AK2304 (Reorder No. 21-0308-01) 118 inch length/300 cm, 19ml priming volume, 60 drops/ml, 3 standard injection sites and 0.22 micron air-eliminating filter.

FDA Recall
Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=141mm, C=111mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-111.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·December 20, 2004

Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=112mm, C=82mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-82.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·December 20, 2004

Endopath EZ45 Endoscopic Linear Cutter (ET45B).

FDA Recall
Terminated ·Ethicon Endo-Surgery·Product code GDW·November 21, 2004