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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.

Baxter Clearlink System Non-DEHP Minivolume Extension Set, product code 1C8739; An Rx sterile, nonpyrogenic fluid pathway, 8.0'', 0.6 mL Vol., with Luer Activated Valve for IV Access and male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code FPA·December 15, 2005

Stryker Epic Critical Care Bed; Model 2030.

FDA Recall
Terminated ·Stryker Medical·Product code FNL·January 17, 2006

Osteofil ICM Moldable Strip of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

FDA Recall
Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

Baxter BM11 Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 5M3005, 5M3005R

FDA Recall
Terminated ·Baxter Healthcare Renal Div·Product code KOC·December 21, 2005

Tooth bonding resin. Optibond Solo Plus Bottle Kit, Part Number 31514, Lot Number 429106

FDA Recall
Terminated ·Kerr Corp·Product code KLE·March 3, 2006

Osteofil RT, ICM Allograft Paste in varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

FDA Recall
Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

AXIOM Artis X-ray systems running software versions VB11K and VB22G

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IZI·March 10, 2006

KTV0006-002, AOS Tongue And Soft Tissue Kit: AOS Tngue And Soft Tissue Inplant Tubes (20EA); 20CM S.S. Implant Needles, 14 Degrees (20EA)

FDA Recall
Terminated ·Alpha Omega Services Inc·Product code JAQ·February 21, 2006

CALM software, version 02.09.01 This software is intended for use as a central monitoring system with signal analysis and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.

FDA Recall
Terminated ·LMS Medical Systems Ltd·Product code HGM·January 11, 2005

IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The IntraStent DoubleStrut LD Biliary Stent is a balloon expandable stent. It is intended as a permanently implanted device. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is designed to be crimped onto a non-compliant PTA balloon catheter that is indicated for biliary stent expansion. After mounting onto a balloon catheter, it is deployed and expanded by inflating the balloon.

FDA Recall
Terminated ·Product code FGE·December 29, 2005