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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.
Tyco Healthcare Monoject Prefill 100UlmL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula REF # 8881591125, Tyco Healthcare, Mansfield, MA 02048
FDA Recall
Terminated
·Product code NZW·March 28, 2008
Myelotec Steerable Video Guided Catheter, 3.0mm, Label Insert contained in LB0020-0, LB0020-1, LB0020-2, LB0020-3, and LB0020-4 (Product Code: 2010). Myelotech, Roswell, GA 30076.
FDA Recall
Terminated
·Myelotec, Inc.·Product code HRX·December 19, 2007
Peel-Away Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer, 9 CM long, Wire: .035" DIA., 30 CM long, 3 MM J needle: 18 ga., 4.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLIP-7.0-35. Cook Inc., Bloomington, IN 47404
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·December 7, 2007
Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog Number: 255103; Product Number: M0062551030, Onset Medical, Boston Scientific Corp., Natick, MA 01760
FDA Recall
Terminated
·Boston Scientific Corporation·Product code EZN·November 30, 2007
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00219W, 24F x 4.4cm, 20cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device.
FDA Recall
Terminated
·C R Bard Inc·Product code KNT·December 22, 2008
Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P800 Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 04998669001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JJE·November 12, 2008
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00201W, 16F x 1.7cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device.
FDA Recall
Terminated
·C R Bard Inc·Product code KNT·December 22, 2008
Pilling(R) Coronary Scissors, 60Deg 7", Catalog numbers: 352166, Teleflex Medical, Research Triangle Park, NC 27709
FDA Recall
Terminated
·Teleflex Medical·Product code LRW·March 3, 2009
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00221W, 18F x 1.2cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device.
FDA Recall
Terminated
·C R Bard Inc·Product code KNT·December 22, 2008
PDS II (polydioxanone) Suture, Ethicon, Inc., A Johnson & Johnson Company, Somerville, NJ. Sutures are intended for general soft tissue approximation and/or ligation.
FDA Recall
Terminated
·Ethicon, Inc. US·Product code GAM·February 2, 2009