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Displaying 1 - 15 of 426 items.
The recall is being done because the device does not meet the requirements of the MDR. Specifically, the devices implanted are not on the device system's active license 104252.
Recall start date: March 1, 2023
RecallHealth product recall | 2023-03-15
Vials may be cracked in affected lots.
RecallHealth product recall | 2023-03-03
If the walker isn't being used as per original design, (e.g. if the chest pad with stem is omitted or is extended beyond capacity to allow for sufficient holding), and the screw is loose, the Pommel may fall off, potentially resulting in a fall.…
RecallHealth product recall | 2023-03-01
Potential low Anti-Factor Ila potency out of specification.
RecallHealth product recall | 2023-03-01
Bacteria content is below specification in the affected lot.
RecallHealth product recall | 2023-03-01
Bacteria content is below specification in the affected lot.
RecallHealth product recall | 2023-03-01
Affected lots are incorrectly labelled for use in the pediatric subpopulation.
RecallHealth product recall | 2023-02-24
Freestyle Libre 2 Application (app) users on the Android 13 Operating System (OS), with alarms enabled, may experience situations of extended bluetooth connection loss which results in persistent signal loss conditions preventing glucose alarm function.…
RecallHealth product recall | 2023-02-24
Results of post market surveillance revealed that under certain circumstances the room configuration parameters of the system are set to default values. If these values are larger than the actual room dimensions, a collision with the ceiling or wall…
RecallHealth product recall | 2023-02-24
The dissolution is out of specification in the affected lot.
RecallHealth product recall | 2023-02-17
It was identified that two (2) Freestyle Libre sensor reel lots manufactured by Abbott Diabetes Care (ADC) failed retain testing. As a result of the investigation and testing of retains, the sensors were found to give clinically significant readings…
RecallHealth product recall | 2023-02-16
Affected lot being voluntarily recalled due to reported adverse reactions possibly to niacin (reddening skin flush, heat sensation).
RecallHealth product recall | 2023-02-14
The affected lot may contain the presence of foreign matter.
RecallHealth product recall | 2023-02-14
Presence of foreign matter in affected lot.
RecallHealth product recall | 2023-02-13
Siemens Healthcare is information customers of a potential issue with the Artis system in combination with a Siemens Healthineers table or a Trumpf/Maquet table. There are 3 potential issues depending on the combination of the Artis Pheno and type of…
RecallHealth product recall | 2023-02-10