The Recall Desk
ModerateFDA (Devices)·Z-0769-2018·Announced 2018-03-07

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

Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical 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 'transference of ink,' with no reported injuries or illnesses. This aligns with the rubric for moderate severity involving minor defects or low-risk contamination where the primary impact is cosmetic or theoretical.

Plain-English summary

Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches (Model # 884515, Lot # 161236A and #170236A) due to a defect in the purple ink used on the exterior labels. The recall involves 50 units distributed nationwide in the United States.

On June 15, 2017, Steris identified that the purple ink on the outside label may migrate following steam processing. This migration can cause cosmetic defects on the exterior of the pouch and, in some instances, result in the transfer of ink onto the medical devices contained within the pouch. The pouches are designed to maintain the sterility of properly processed medical devices during handling and storage.

Healthcare providers who have purchased these specific lots should stop using them and contact Steris Corporation for further instructions. This recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed
Manufacturer
Steris Corporation
Category
Medical Device — Sterilization Pouches
Hazard
Affected units
50

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)

  • Model# 884515 Lot# 161236A and #170236A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 29 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 29 products in this recall →

Related recalls

Same manufacturer · Steris Corporation

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Same hazard · ink migration

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