🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
All Recalls
95,050 total recalls in our database
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices Class I - Dangerous
Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported
Drill, 2.7x125mm, AO , Item Number ST502015217
Zimmer GmbH
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Drill, 3.2x145mm, AO, Item Number 502015650
Zimmer GmbH
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics
🏥 Medical Devices Class I - Dangerous
Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.