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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.

remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402, 10/pk, each Tyvek pouch contains 1 tube of medium and 1 rayon-tipped sterile swab. The firm name on the label is remel, Lenexa, KS. Product is a sterile system recommended for use in qualitative procedures for the collection of clinical specimens and transport to the laboratory for microbiological culture of anaerobic, facultative, and aerobic organisms.

FDA Recall
Terminated ·Remel, Inc·Product code JSM·January 18, 2010

Centurion Healthcare Products Pump Fill Kit DT10175. CONTENTS: 1 CSR WRAP, 2 GLOVES, 1 FENESTRATED DRAPE, 1 EXTENSION LINE Approx. Priming Vol.: 0.3mL, 1 SYRINGE, 1 Exel Huber NEEDLE, 1 ChloraPrep(R), 1 TRAY The recalled Exel Huber Needles are used to access subcutaneously implanted ports used for the withdrawal of blood samples and infusion of medication. The firm places the recalled needles in pump fill kit.

FDA Recall
Terminated ·Centurion Medical Products·Product code FMI·February 1, 2010

Femoral Sponge 10 inches REF 206-715, Rx Sterile, Stryker Instruments Kalamazoo, MI. The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GDY·January 25, 2010

Aplio 80; SSA-770A; software version 5.5r002

FDA Recall
Terminated ·Toshiba American Medical Systems Inc·Product code IYN·November 12, 2007

Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port, for the introduction of various types of pacing or defibrillator leads and catheters. The product is shipped 5 per carton. Product is distributed by Pressure Products. Catalog numbers: CSG/MSP-00-09, CSG/90-09, CSG-KR-90-09, CSG/WORLEY-1-09, CSG-WORLEY-Bcor-1-09, CSG/WORLEY/L/Bcor-1-09, CSG/WORLEY-2-09, CSG/WORLEY/Bcor-2-09, CSGMSP0009M, CSGWORLEY109M, CSGWORL19M, CSGWORBC19M, CSGWORLBC19M, CSGWORBC29M, CSG/Worley/BCor-1-07, CSG/Worley/BCor-2-07, CSG/WORLEY/BCOR-M-09, and CSG/Worley/R-1-09.

FDA Recall
Terminated ·Thomas Medical Products Inc·Product code DYB·December 17, 2009

BD Nexiva Closed IV Catheter System, REF 383536, 20GA 1.00IN, Becton Dickinson Infusion Therapy Systems Inc.

FDA Recall
Terminated ·Becton Dickinson Medical Systems·Product code FOZ·October 19, 2009

MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164

FDA Recall
Terminated ·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009

Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalog Number: SMB000101

FDA Recall
Terminated ·TAG Medical Corp. Kibbutz Gaaton Naharia Israel·Product code NBH·December 4, 2009

Spacelabs Model 91367 SL 2200 Compact Monitor Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products.

FDA Recall
Terminated ·Spacelabs Healthcare, Incorporated·Product code DXJ·November 6, 2009

Infinia with Hawkeye 1, model numbers: H2508PW, H2508PY, H3000WN, H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000YS. GE Healthcare, Waukesha, Wisconsin 53118. Generating head and whole body CT images of human subjects

FDA Recall
Terminated ·GE Medical Systems, LLC·Product code JAK·August 1, 2009