199 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B
FDA Recall
Open, Classified
·Product code RDE·November 26, 2025
00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML, Rx, Sterile; 00598706202 Provisional CRA FEM PROV/CUT GDE SZ BMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·June 7, 2013
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code KPR·July 12, 2024
Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part number 110-0234G1 (domestic) and 110-0234G3 (international) The Orthoralix 8500 DDE Panoramic Dental X-Ray System is used as an extraoral source of x-rays for imaging of the dento-maxillofacial area.
FDA Recall
Terminated
·Gendex Dental Systems·Product code EHD·December 21, 2010
Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
FDA Recall
Terminated
·Materialise USA LLC·Product code JWH·May 3, 2016
LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223
FDA Recall
Terminated
·GMP Companies/Lifesync Corporation·Product code DRG·January 10, 2007
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
FDA Recall
Terminated
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NIK·November 15, 2020
Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
FDA Recall
Terminated
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NIK·November 15, 2020
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Recall
Terminated
·Clinical Diagnostic Solutions·Product code JPK·March 24, 2011
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Recall
Terminated
·Clinical Diagnostic Solutions·Product code JPK·March 24, 2011
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Recall
Terminated
·Clinical Diagnostic Solutions·Product code JPK·March 24, 2011
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
FDA Recall
Terminated
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NIK·November 15, 2020
Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.
FDA Recall
Open, Classified
·DRE Medical Group Inc·Product code MNT·May 15, 2023
AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016
Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016
AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016
Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
FDA Recall
Terminated
·Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·August 20, 2013
The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a patients age, previous biopsy, and digital rectal exam (DRE). Patients file (sample type, prior biopsy status, DRE status and age) are uploaded to the Specimen Processing Module (SPM). The results from the four assays are exported automatically to Lab Manager Application (B2 LIS) which automatically triggers the 4Kscore calculation when values of the four analytes are available. The 4Kscore test results are determined automatically by the validated laboratory information system algorithm calculation software.
FDA Recall
Open, Classified
·BioReference Health, LLC·Product code QRF·November 18, 2022