Agency classClass IIOur severity:Low FDA (Devices)·Z-0799-2021·Announced 2021-01-13

Steris Vis-U-All Pouches Recalled for Ink Migration on Exterior Labels

Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects or 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 causing 'cosmetic defects' and ink transfer, with no reported injuries or illnesses. Per the rubric, cosmetic defects and packaging-only problems are classified as Low severity.

Plain-English summary

Steris Corporation is recalling Vis-U-All High Temp 8"x16" Self Seal Pouches, Model Number 884816. The recall involves 46 cases of the product, which are distributed nationwide and to foreign locations. The specific lot number for the affected product is 200438A.

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. In some instances, the ink may also transfer onto the medical devices contained within the pouch.

The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself. No illnesses, injuries, or deaths are reported in the source text.

The recalled product

Product: Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884816
Manufacturer: Steris Corporation
Category: Medical Device — Sterilization Pouches
Hazard: cosmetic-defect
ink-migration
Affected units: 46

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: 200438A

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

See all →

Severe
Steris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
Severe
Steris VERIFY Biological/Integrator Challenge Pack Recall for Sterilization Monitoring Failure
FDA (Devices) · 2026-10-14
Severe
Steris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
Severe
Steris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
Severe
Steris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14

Same hazard · cosmetic defect