The Recall Desk
ModerateFDA (Devices)·Z-0759-2018·Announced 2018-03-07

Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration

Steris Corporation is recalling Vis-U-All High Temp Heat Seal 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 the ink,' with no mention of injury, illness, or functional failure of the sterilization process. This aligns with the rubric for moderate severity involving minor defects or low-risk issues.

Plain-English summary

Steris Corporation is recalling Vis-U-All High Temp 8"x10" Heat Seal Pouches (Model# 883810, Lot# 161126A) due to a defect in the purple ink used on the exterior labels. The recall was initiated after the company identified that the ink may migrate following steam processing.

This migration can cause cosmetic defects on the outside of the pouch and, in some instances, result in the ink transferring onto the medical devices contained within. The affected product is distributed nationwide in the United States. The pouches are designed for healthcare providers to enclose and seal medical devices for steam sterilization.

Healthcare providers should stop using the affected pouches and contact Steris Corporation for further instructions. The recall is classified as Class II by the FDA, indicating that use of the product could 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 8"x10" Heat Seal Pouch 200 pouches per box; 5 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
5

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# 883810 Lot# 161126A

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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