95,025 total recalls in our database
Sky Medical Supplies and Equipments
Distributed COVID test kits without emergency use authorization.
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Carl Zeiss Meditec AG
When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of the screen
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary treatment or quarantine.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.
Combat Medical Systems
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing).
Combat Medical Systems
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.