SEO landing

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.

ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511038001. AC FLEXLINK PLUS 10MM CANNULA. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc. Fishers, IN 46037, USA Toll Free: 1-800-280-7801 Roche Diabetes Care AG 3401 Burgdorf, Switzerland

FDA Recall
Terminated ·Roche Insulin Delivery Systems Inc.·Product code FRN·February 24, 2011

Hospira Plum XL Micro/Macro with DataPort Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list number 11859

FDA Recall
Terminated ·Hospira Inc.·Product code FRN·February 14, 2011

ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510970001. AC FLEXLINK PLUS INF 6/40 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc. Fishers, IN 46037, USA Toll Free: 1-800-280-7801 Roche Diabetes Care AG 3401 Burgdorf, Switzerland

FDA Recall
Terminated ·Roche Insulin Delivery Systems Inc.·Product code FRN·February 24, 2011

Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 5cm, C-UDLMY-401J-PED-ABRM-HC-IHI-FST, G48059, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

FDA Recall
Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Minipuncture Access, 8.0 Fr/ 15cm, C-UDLMY-801J-MNP-ABRM-HC-FST-A, G44069, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

FDA Recall
Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

HomeFill Oxygen Compressor IOH200 Homefill, The serial numbers are as follows: 10JF034081, 10JF034082, 10JF034083, 10JF034084, 10JF034085, 10JF034086, 10JF034087, 10JF034088, 10JF034089, 10JF034090, 10JF034091, 10JF034092, 10JF034093, 10JF034094, 10JF034095, 10JF034096, 10JF034097, 10JF034098, 10JF034099, 10JF034100, 10JF034101, 10JF034102, 10JF034103, 10JF034104, 10JF034105, 10JF034106, 10JF034107, 10JF034108, 10JF034109, 10JF034111, 10JF034112, 10JF034113, 10JF034114, 10JF034115, 10JF034116, 10JF034117, 10JF034119, 10JF034120, 10JF034121, 10JF034122, 10JF034123, 10JF034124, 10JF034125, 10JF034126, 10JF034127, 10JF034128, 10JF034129, 10JF034130, 10JF034131, 10JF034132, 10JF034133, 10JF034134, 10JF034135, 10JF034136, 10JF034177, 10JF034178, 10JF034179, 10JF034180, 10JF034181, 10JF034182, 10JF034183, & 10JF034184. The IOH 200 Homefill is an electromechanical, prescription device designed for use in the home. Its intended function and use is to provide supplemental oxygen to patients and to supply pressurized oxygen to fill cylinders for the patients personal ambulatory use.

FDA Recall
Terminated ·Invacare Corporation·Product code CAW·January 11, 2011

Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/12cm, CUTLMY501JRSCCCT, G26945, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

FDA Recall
Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0Fr/8cm, C-UDLMY-401J-CCT, G26927, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

FDA Recall
Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25cm, C-UTLMY-701J-LSC-ABRM-HC-FST-RD, G47832, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

FDA Recall
Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 5.0 Fr/5 cm, CUDLMY501JPED- ABRM-HC-FST, G43982, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

FDA Recall
Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010