All Recalls

95,025 total recalls in our database

When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.

Apr 7, 2020 Surgical Instruments Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computers metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the devices CD-ROM.

Mar 30, 2020 Other Medical Devices Nationwide View Details β†’

Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the unplugging of the main cable can cause an unsafe electrical voltage (125 V DC) at the X10 connector and result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. These contact pins are accessible when the main cable is unplugged from the X10 connector

Apr 20, 2020 Diagnostic Equipment Nationwide View Details β†’

Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2ΒΏC. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment

Apr 30, 2020 Diagnostic Equipment Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.

Nov 21, 2018 Surgical Instruments View Details β†’

Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2ΒΏC. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment

Apr 30, 2020 Diagnostic Equipment Nationwide View Details β†’

Saline Flush Syringe compromised sterility due to holes in the packaging.

Apr 23, 2020 Surgical Instruments Nationwide View Details β†’

When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If this happens, live parts may be exposed (230 V) and/or the video signal can be lost.

Apr 10, 2020 Diagnostic Equipment Nationwide View Details β†’

Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2ΒΏC. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment

Apr 30, 2020 Diagnostic Equipment Nationwide View Details β†’

Saline Flush Syringe compromised sterility due to holes in the packaging.

Apr 23, 2020 Surgical Instruments Nationwide View Details β†’

Saline Flush Syringe compromised sterility due to holes in the packaging.

Apr 23, 2020 Surgical Instruments Nationwide View Details β†’

Saline Flush Syringe compromised sterility due to holes in the packaging.

Apr 23, 2020 Surgical Instruments Nationwide View Details β†’

da Vinci X Surgical System

Intuitive Surgical

πŸ₯ Medical Devices Class I - Dangerous

Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.

Nov 21, 2018 Surgical Instruments View Details β†’