The Recall Desk
ModerateFDA (Devices)·Z-0790-2021·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 during steam processing, causing cosmetic defects and potential ink transfer to devices inside.

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, which aligns with the rubric's criteria for moderate severity involving minor defects or low-risk issues without reported serious injury.

Plain-English summary

Steris Corporation is voluntarily recalling Vis-U-All High Temp 4.5"x11" Heat Seal Pouches, Model Number 883411. The recall involves 53 cases of the product, which were distributed nationwide and to foreign locations. The specific lot numbers affected are 200421A and 200521A.

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.

Healthcare facilities and consumers who have purchased these specific pouches should stop using them and contact Steris Corporation for further instructions or a refund. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883411
Manufacturer
Steris Corporation
Category
Medical Device — Sterilization Pouches
Hazard
Affected units
53

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: 200421A
  • 200521A

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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