Agency classClass IIOur severity:Low FDA (Devices)·Z-0798-2021·Announced 2021-01-13

Steris Recalls Vis-U-All Pouches Due to Ink Migration Defects

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 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 source text explicitly describes the issue as causing 'cosmetic defects' and notes that no illnesses or injuries have been reported, fitting the rubric criteria for cosmetic defects and packaging-only problems.

Plain-English summary

Steris Corporation is voluntarily recalling Vis-U-All High Temp 7.5"x13" Self Seal Pouches, Model Number 884713. The recall involves 201 cases, with 200 pouches per box and 4 boxes per case. The affected lot numbers are 200437A and 200637A. The product was distributed nationwide and to foreign locations.

The recall was initiated because purple ink located on the outside label of the pouches may migrate or bleed following steam processing. This issue causes cosmetic defects on the exterior of the pouch. In some instances, the ink may transfer onto the medical devices contained within the pouch.

No illnesses or injuries have been reported in connection with this recall. The FDA has classified this as a Class II recall. Users should stop using the affected pouches and contact Steris Corporation for further instructions or a refund.

The recalled product

Product: Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884713
Manufacturer: Steris Corporation
Category: Medical Device — Sterilization Pouches
Hazard: cosmetic-defect
ink-migration
Affected units: 201

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: 200437A
200637A

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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Same hazard · cosmetic defect