Medical Devices Recalls

This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old RF board design will be replaced with the newly designed CU 4.0 consoles.

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up diagnostic procedure, i.e., colonoscopy or sigmoidoscopy

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.

Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety function of the board would be insufficient resulting in an increased leakage of current and potentially cause electrical shocks to the user.

RevMedX Trauma Dressing is being recalled due to package seal integrity.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.

The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.