97 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Access Thyroglobulin, A34085G, Catalog No. 33860
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code MSW·May 9, 2017
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code MSW·April 30, 2019
Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code MSW·July 28, 2015
IMMULITE /IMMULITE 1000 TG
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code MSW·January 2, 2018
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # L2KTY2(D) Siemens Material Number (SMN): 10381647
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code MSW·December 7, 2022
Access Thyroglobulin Calibrators
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code MSW·July 6, 2023
IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # Catalog # L2KTY2 Siemens Material Number (SMN): 10381648
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code MSW·December 7, 2022
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code MSW·July 10, 2025
Access Immunoassay Systems Thyroglobulin, Part Number: 33860 This device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin antibodies.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code MSW·October 18, 2010
IMMULITE 2000/IMMULITE 2000 XPi TG
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code MSW·January 2, 2018
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
FDA Recall
Open, Classified
·Nexstim PLC Elimaenkatu 9B Helsinki Finland·Product code GWF·March 14, 2017
Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
FDA Recall
Terminated
·Carestream Health Inc.·Product code KPR·June 3, 2013
epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics Inc·Product code CHL·December 12, 2022
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, Refurbished 10736433 epoc Host 2, US (MC55X) 11413524 epoc Host 2, ROW (MC55X) 11413528 epoc Host 2, India (MC55X) 11413541 epoc Host 2, China (MC55X) 11413542 epoc Host 2, Japan (MC55X) 11413543 epoc Host 2 (MC55X) - US - Refurbished 11413601 "epoc Host 2 (MC55X) - ROW -Refurbished" 11413602 epoc Host 2 (MC55X) - India - Refurbished 11413603 epoc Host 2 (MC55X) - Japan - Refurbished 11413604
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics Inc·Product code CHL·December 12, 2022
Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWENSBORO DAVIESS HOSP 20058814. 3. SESK MEMORIAL HEALTH SYSTEM SPINAL/EPID. 4. SESK ST. JOHN'S MERCY MED CTR SPINAL/EPID. 5. SESK MAIMONIDES HOSPITAL SPINAL/EPIDURAL. 6. SESK OU MEDICAL CENTER - SPINAL/EPIDURAL. 7. SESK ELLIS HOSPITAL - SPINAL EPIDURAL. 8. STONY BROOK HSP SPINAL EPIDRAL TRAY SESK. 9. SESK UAB SPINAL EPIDURAL. 10. SESK CREIGHTON UNIV BMH SOINAL EPIDURAL. 11. SESK, BSW SPINAL EPIDURAL TRAY. 12. LYNDON B JOHNSON HOSPITAL SPINAL EPID.
FDA Recall
Open, Classified
·B BRAUN MEDICAL INC·Product code OGE·September 18, 2025
RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use
FDA Recall
Terminated
·Ability Dynamics LLC·Product code ISW·June 2, 2014
Polyflex Esophageal Stent 20/16mm x 90mm
FDA Recall
Terminated
·Boston Scientific Corporation·Product code ESW·April 16, 2003
Polyflex Esophageal Stent 20/16mm x 120mm
FDA Recall
Terminated
·Boston Scientific Corporation·Product code ESW·April 16, 2003
Boston Scientific Ultraflex Covered large Esophageal Stent System - Distal Release (23/28/10/7) Material/UPN/Catalog Number: M00514200
FDA Recall
Terminated
·Boston Scientific Corporation·Product code ESW·July 15, 2010