Agency classClass IIOur severity:Low FDA (Devices)·Z-0794-2021·Announced 2021-01-13

Steris Vis-U-All Pouches Recalled for Ink Migration

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

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 describes the hazard as 'cosmetic defects' and ink transference, with no mention of injury, illness, or functional failure. This aligns with the rubric for cosmetic defects and packaging-only problems.

Plain-English summary

Steris Corporation is voluntarily recalling 589 cases of Vis-U-All High Temp 13"x18" Self Seal Pouches, Model Number 884118. The recall is due to purple ink located on the outside label of the pouches, which may migrate or bleed following steam processing.

This migration 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 affected product is identified by Lot Number 200430A and was distributed nationwide and to foreign locations.

The source text does not specify specific actions for consumers or healthcare providers, such as whether to stop use or return the product. Users should refer to the official FDA recall notice or contact the manufacturer for specific instructions regarding the affected lot.

The recalled product

Product: Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118
Manufacturer: Steris Corporation
Category: Medical Device — Sterilization Pouches
Hazard: cosmetic-defect
ink-migration
Affected units: 589

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: 200430A

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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