132 results
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19ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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GEM Premier 5000; Part No: 00055415011.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code LFL·September 12, 2023
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics Inc·Product code CHL·March 19, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CHL·November 22, 2024
epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CHL·November 22, 2024
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code LFL·October 22, 2025
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code LFL·October 22, 2025
Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code LFL·October 22, 2025
Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code LFL·October 22, 2025
GEM Premier 5000 PAK, Part No. 00055360004.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
GEM Premier 5000; Part No. 00055430008.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
GEM Premier 5000 PAK; Part No. 00055360011.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
GEM Premier 5000; Part No. 00055415005.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
GEM Premier 5000 PAK; Part No. 00055360008.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics Inc·Product code CHL·April 2, 2026
ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
FDA Recall
Open, Classified
·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code CHL·May 18, 2022
GEM Premier 5000; Part No. 00055445004.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
GEM Premier 5000; Part No. 00055415010.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
GEM Premier 5000 PAK; Part No. 00055407508.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
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