Steris Corporation: Medical Device Recall in 2021 - (Recall #: Z-0795-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884411

Product Classification:

Class II

Date Initiated: December 2, 2020

Date Posted: January 13, 2021

Recall Number: Z-0795-2021

Event ID: 86942

Reason for Recall:

Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch

Status: Terminated

Product Quantity: 43 cases

Code Information:

Lot Number: 200434A

Distribution Pattern:

Nationwide Foreign:

Voluntary or Mandated:

Voluntary: Firm initiated