All Recalls

95,050 total recalls in our database

When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.

Dec 5, 2018 Surgical Instruments Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short circuit.

Feb 12, 2019 Patient Monitors View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short circuit.

Feb 12, 2019 Patient Monitors View Details β†’

When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.

Dec 5, 2018 Other Medical Devices Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short circuit.

Feb 12, 2019 Patient Monitors View Details β†’

Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the packaging being too similar to domestically sourced products under the same branded label.

Feb 27, 2019 Diagnostic Equipment Nationwide View Details β†’

GO travel sleep sound machines

Marpac, LLC, of Wilmington, N.C.

🏠 Consumer Products Class II - Moderate

The sound machine's internal battery can leak and cause an electrical short, posing a burn hazard.

Apr 9, 2019 Electronics Nationwide View Details β†’

Hot/cold massage balls

Sakar International

🏠 Consumer Products Class II - Moderate

The massage balls can leak or rupture during or after microwaving, posing a burn hazard to consumers.

Apr 4, 2019 Other Consumer Products Nationwide View Details β†’