The Recall Desk
ModerateFDA (Devices)·Z-0786-2021·Announced 2021-01-13

Steris Recalls Vis-U-All High Temperature Tubing Due to Ink Migration

Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the exterior label may bleed during 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 issue as causing 'cosmetic defects' and ink transfer, with no reported injuries or illnesses. This aligns with the rubric for moderate severity involving minor labeling or cosmetic issues without significant health risk.

Plain-English summary

Steris Corporation is recalling 7 cases of Vis-U-All High Temperature Tubing, Model Number 881031, Lot Number 200505A. The product is distributed nationwide and in foreign markets. The recall was initiated because purple ink located on the outside label of the Vis-U-All Pouches may migrate or bleed following steam processing.

This ink migration can cause cosmetic defects on the exterior of the pouch. In some instances, the ink may transfer onto the medical devices contained within the pouch. The source text does not report any illnesses, injuries, or deaths associated with this recall.

Users of this product should stop using the affected tubing and contact Steris Corporation for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031
Manufacturer
Steris Corporation
Category
Medical Device — Sterilization Supplies
Hazard
Affected units
7

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 (1)

  • Lot Number: 200505A

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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