30 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
FDA Recall
Open, Classified
·Roche Diagnostics Operations, Inc.·Product code MMI·April 7, 2021
Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
FDA Recall
Open, Classified
·Roche Diagnostics Operations, Inc.·Product code MMI·April 7, 2021
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
FDA Recall
Open, Classified
·ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom·Product code MMI·June 5, 2023
VITROS Immunodiagnostic Products Troponin I ES Calibrators
FDA Recall
Open, Classified
·ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom·Product code MMI·June 5, 2023
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
FDA Recall
Open, Classified
·Abbott Laboratories·Product code MMI·July 26, 2022
Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.
FDA Recall
Open, Classified
·QUIDEL CARDIOVASCULAR INC·Product code MMI·May 25, 2023
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code MMI·November 18, 2024
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code MMI·August 9, 2021
Ami HTX.
FDA Recall
Open, Classified
·Spectral Instruments Inc·Product code RCE·May 13, 2025
Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
FDA Recall
Open, Classified
·Universal Meditech Inc.·Product code LCX·May 22, 2023
MIM software; System, Image Processing, Radiological
FDA Recall
Open, Classified
·MIM Software Inc·Product code LLZ·February 19, 2025
Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. (4) a safety shield, The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.
FDA Recall
Open, Classified
·Guangzhou Improve Medical Instruments Co., Ltd. NO.·Product code FMI·September 22, 2017
Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
FDA Recall
Open, Classified
·Teleflex Medical·Product code FMI·October 8, 2019
Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A
FDA Recall
Open, Classified
·Waismed Ltd. 11, Galgalei Ha-Plada Pob 12135 Herzliya Israel·Product code FMI·June 5, 2025
Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.
FDA Recall
Open, Classified
·C.A. Greiner & Sohne Gesellschaftmbh Greiner St. # 70 Kremsmunster Austria·Product code FMI·July 27, 2020
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
FDA Recall
Open, Classified
·Bard Peripheral Vascular Inc·Product code FMI·July 27, 2021
VACUETTE SAFELINK, REF: 450210
FDA Recall
Open, Classified
·Greiner Bio-One GmbH Bad Haller Strase·Product code FMI·November 19, 2024
Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
FDA Recall
Open, Classified
·Teleflex Medical·Product code FMI·October 8, 2019
Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
FDA Recall
Open, Classified
·Teleflex Medical·Product code FMI·October 8, 2019
Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A
FDA Recall
Open, Classified
·Waismed Ltd. 11, Galgalei Ha-Plada Pob 12135 Herzliya Israel·Product code FMI·June 5, 2025