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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.

Liquid Alk Phos Reagent, Catalog No. 3-A7516-L, In vitro diagnostic, Sold by Pointe Scientific.

FDA Recall
Terminated ·Pointe Scientific, Inc.·Product code CJE·February 7, 2008

Stryker 4.0mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-140.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBE·January 10, 2008

RP Diaphragm Exhalation model number FC06372. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall
Terminated ·Respironics, Inc.·Product code CBK·October 15, 2007

Stryker 3.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-30.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBE·January 10, 2008

RP-Assy, Cover, DC-5 pack model number F35933. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall
Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

Non-continuous ventilator accessories under the following brand names: a) RP-L ComfortGel Cush and Flap model number 1031404 and b) RP-M ComfortGel Cush and Flap model number 1031403. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall
Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

Stryker GMRS Proximal Femoral Surgical Protocol; Global Modular Replacement System Proximal Femoral Resection for Large Segmental Replacements, Femur Prosthesis Surgical Literature, Stryker Orthopaedics, Mahwah, NJ 07430

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·December 18, 2007

Rotating Connector Packaged model number 302209. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall
Terminated ·Respironics, Inc.·Product code CBK·October 15, 2007

Stryker 3.1mm x 19.1mm Straight Router, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-70-31.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBE·January 10, 2008

Stryker 3.1 mm x 19.1 mm Straight Router, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-70-31.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBE·January 10, 2008