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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.

Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City, CA 94063

FDA Recall
Terminated ·Rubicor Medical·Product code GEI·February 17, 2006

METRx II Tube, 18mm x 4cm stainless steel tubular retractor, Part No. 9569681

FDA Recall
Terminated ·Medtronic Sofamor Danek Instrument Manufacturing·Product code LXH·January 25, 2006

LigaSure Atlas Laparoscopic Vessel Sealer/Divider

FDA Recall
Terminated ·Covidien LP·Product code GEI·January 27, 2006

Roche MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog number 03264793001.

FDA Recall
Terminated ·Roche Diagnostics Corp.·Product code NPQ·April 4, 2006

ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle Screws) Item Number 54-1090 ICON Instrument Case 1 Item Number: 54-1091 ICON Instrument Case 2 Item Number: 54-1092

FDA Recall
Terminated ·Blackstone Medical Inc.·Product code KWQ·December 23, 2005

Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., Basingstoke, Hants, England

FDA Recall
Terminated ·Remel, Inc.·Product code KTN·February 14, 2006

Baxter Interlink System Minivolume Extension Set, product code 1C8290; An Rx sterile, nonpyrogenic fluid pathway, 11.0'', 0.86 mL Vol., with 2 injection sites 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 PainPump1 Base Kit; Product number 500-100-000.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEA·February 3, 2006

Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm. Manual surgical instrument for general use.

FDA Recall
Terminated ·International Technidyne Corp·Product code FMK·January 23, 2006

Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540.

FDA Recall
Terminated ·Cook Urological, Inc.·Product code FAD·March 1, 2006