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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.
ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system. Siemens Medical Solutions USA, Inc., Mountain View, CA
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·September 25, 2007
Stryker 6.0mm x 7.9 mm Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-60.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code HBE·January 10, 2008
Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-10 mL vial; 25 pack, NDC 0641-2438-45, (NDC 0641-2348-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008
Mevatron KDS-2 Medical Linear Accelerator, Material Number: 9822693, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·January 11, 2008
Coloplast Elefant Suction/Irrigation Tubing, Part Number: AST 307, Coloplast Corp., Minneapolis, MN 55411
FDA Recall
Terminated
·Coloplast Corp·Product code FQH·November 12, 2007
Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 10 units/mL-1 mL vial, 25 pack, NDC 0641-0272-25 (NDC 0641-0272-21: on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008
MEVATRON M-2 6300 Medical Linear Accelerator, Material Number: 09401316 with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·January 11, 2008
Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210517. The product is shipped 4 units per shipping carton. Hemodialysis kit, B. Braun Medical, Inc., Allentown, PA 18109
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FJK·December 10, 2007
Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 100 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc., Glendale Heights, IL 60139 The pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC #64253-333-35, catalog #MIH-3335: 5 mL fill in 12 mL syringe b) NDC #64253-333-33, catalog #MIH-3333: 3 mL fill in 12 mL syringe c) NDC #64253-333-23, catalog #MIH-3323: 3 mL fill in 6 mL syringe
FDA Recall
Terminated
·Medefil Incorporated·Product code NZW·March 20, 2008
Boston Scientific Mach 1 peripheral Guide Catheter 6F, HS Hockey Stick, .070 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-600, UPN M001196000, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311
FDA Recall
Terminated
·Boston Scientific Corporation One Boston·Product code DQY·February 7, 2008