Steris recalls 100-pouch boxes of Vis-U-All High Temp Pouches due to purple ink bleeding after steam processing, potentially leaving ink on medical devices.
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
Steris is recalling high-temperature self-seal pouches that may bleed purple ink after steam processing. This could cause ink to transfer to medical devices, though it's a cosmetic issue with no reported injuries.
Purple ink on the pouch label can migrate to the pouch's exterior and onto medical devices after steam processing. This may cause visible ink transfer but does not affect device function or safety.
Users of medical sterilization pouches, particularly healthcare facilities using these products for sterilizing medical devices. The risk is low as the ink transfer is cosmetic and not linked to injury.
Check for model number 884118 on the pouch box. The product was sold with lot number 200430A. These pouches are used in medical sterilization processes.
Look for model number 884118 and lot number 200430A on the pouch box.
No, the ink transfer is cosmetic and does not cause injury or affect device function.
Check for model number 884118 and lot number 200430A on the pouch box.
The recall does not require action as the ink transfer is cosmetic and not linked to injury.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-0794-2021 — Steris Steris Hello, I own a Steris that is covered by recall Z-0794-2021 from Steris. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
