All Recalls

The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.

Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation

The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when stored at room temperature. Ongoing stability studies have indicated the need to shorten the life of the RPC Buffer once resuspended from the current instruction of one week to two days when stored at room temperature (15degC-30degC).

There is a potential for abnormal (non-sigmoidal) amplification curves.

The dosage information on the pouch is incorrect; the primary carton label is correct.

There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.

There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.

Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury

There is an issue with the installation of updated camera firmware on the system.

Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury

Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available

(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expiration date leading to potential erroneous patient sample results

There have been reports of stent migration.

A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.

The youth ATVs fail to comply with the requirements of the federal mandatory ATV safety standard. Children can operate them above the maximum allowed speed, increasing the risk of a crash that can cause serious injuries. The handlebars pose a laceration hazard should the child rider's body or head impact the handlebars at a high rate of speed such as in a crash. In addition, the parking brake does not prevent the movement of the vehicle at the minimum required steepness. ATVs that fail to meet the mandatory safety requirements pose a risk of serious injury or death to children.

Young children can become entrapped in the space between the exterior landing (hoistway) door and the interior elevator car door or gate if there is a hazardous gap, and suffer serious injuries or death when the elevator is called to another floor.

Young children can become entrapped in the space between the exterior landing (hoistway) door and the interior elevator car door or gate if there is a hazardous gap, and suffer serious injuries or death when the elevator is called to another floor.

Young children can become entrapped in the space between the exterior landing (hoistway) door and the interior elevator car door or gate due to a hazardous gap, and suffer serious injuries or death when the elevator is called to another floor.