Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–30 of 30 recalls
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in…
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in…
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in…
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.