All Recalls

DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.

Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury

Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.

Some of the tubes may be incorrectly labeled.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.

DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.

There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.