Agency classClass IIOur severity:Low FDA (Devices)·Z-0789-2021·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 inside the pouch.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the issue causes 'cosmetic defects' and 'transference of the ink' without reporting any adverse health consequences, injuries, or illnesses. Per the rubric, cosmetic defects and packaging-only problems without reported harm align with a Low severity score.

Plain-English summary

Steris Corporation is voluntarily recalling 197 cases of Vis-U-All High Temperature Tubing, Model Number 881091, Lot Number 200408A. The product is distributed nationwide and in foreign markets. Each case contains 6 rolls, with one roll per box and 10 boxes per case.

The recall is due to purple ink located on the outside label of the Vis-U-All Pouches. This ink may migrate or bleed following steam processing. This issue causes cosmetic defects on the exterior of the pouch and, in some instances, results in the transference of the ink onto the medical devices contained within the pouch.

No illnesses or injuries have been reported in connection with this recall. The hazard is limited to cosmetic defects and potential ink transfer to the devices. Users should stop using the affected product and contact Steris Corporation for further instructions or a refund.

The recalled product

Product: Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091
Manufacturer: Steris Corporation
Category: Medical Device — Sterilization Pouches
Hazard: cosmetic-defect
ink-migration
Affected units: 197

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: 200408A

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 →

Same manufacturer · Steris Corporation

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