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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.

Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591.

FDA Recall
Terminated ·Roche Diagnostics Corp.·Product code JJE·December 15, 2003

Eclipse Infusion Pump, 250 ml X 250 ml per hour) Part 5001247

FDA Recall
Terminated ·I-Flow Corporation·Product code MEB·August 19, 2002

AxSYM Tricyclic Antidepressants Reagent, Distributed under the following label: AxSYM Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064

FDA Recall
Terminated ·Abbott Health Products, Inc.·Product code LDM·November 17, 2003

Pentalumen TD Thermodilution Catheter, Sterile

FDA Recall
Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code DYG·November 19, 2003

Depuy brand ACE trochanteric nail; sterile, long, left hip, 380 x 11 x 130; Product 925211380.

FDA Recall
Terminated ·Depuy Orthopaedics, Inc.·Product code HSB·December 11, 2003

Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 100 mm; Product 903011100.

FDA Recall
Terminated ·Depuy Orthopaedics, Inc.·Product code HSB·December 11, 2003

Hypoguard Advance Blood Glucose Strips, 10, 50, and 100 strip bottles.

FDA Recall
Terminated ·Hypoguard USA, Inc.·Product code CGA·November 26, 2003

Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8

FDA Recall
Terminated ·Toray Marketing & Sales (America), Inc·Product code FJI·December 30, 2003

VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.

FDA Recall
Terminated ·Cordis Corporation·Product code DQY·December 7, 2004

ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-140.

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