All Recalls

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.

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.

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.

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.

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.

The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.

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

The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.

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

Optical Trocars sterility assurance can not be guaranteed

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.

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.

The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.