The Recall Desk
ModerateFDA (Devices)·Z-0792-2021·Announced 2021-01-13

Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration

Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may bleed after steam processing, causing cosmetic defects and potential ink transfer to devices.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly describes the hazard as causing 'cosmetic defects' and ink transfer, with no mention of adverse health consequences, injury, or hospitalization. This aligns with the rubric for moderate severity involving minor labeling or cosmetic issues.

Plain-English summary

Steris Corporation is voluntarily recalling Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouches, Model Number 883713. The recall involves 31 cases of the product, with lot numbers 200425A and 200625A. The product was distributed nationwide and to foreign markets.

The recall was initiated because purple ink located on the outside label of the pouches may migrate or bleed following steam processing. This issue can cause cosmetic defects on the exterior of the pouch and, in some instances, result in the transference of the ink onto the medical devices contained within the pouch.

The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare facilities should stop using the affected pouches and contact Steris Corporation for further instructions or a refund.

The recalled product

Product
Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713
Manufacturer
Steris Corporation
Category
Medical Device — Sterilization Pouches
Hazard
Affected units
31

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Number: 200425A
  • 200625A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Steris Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Related recalls

Same manufacturer · Steris Corporation

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Same hazard · ink migration

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