Steris Recalls Vis-U-All High Temperature 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
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 'transference of the ink,' which aligns with the rubric's definition of Low severity for cosmetic defects and packaging-only problems.
Plain-English summary
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches (Model # 884322, Lot # 161233A and #170233A). The product is used by healthcare providers to enclose and seal medical devices for steam sterilization. The recall involves 29 units distributed nationwide in the United States.
The recall was initiated after Steris identified that the purple ink on the outside label of the pouches 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.
Healthcare providers should stop using the affected pouches and contact Steris Corporation for further instructions. The issue is described as a cosmetic defect and potential ink transference, with no mention of reported illnesses or injuries in the source text.
The recalled product
- Product
- Vis-U-All High Temp 3.5"x22" 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 designe
- Manufacturer
- Steris Corporation
- Affected units
- 29
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# 884322 Lot# 161233A and #170233A
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
See all →- ModerateHarmonyAIR A-Series surgical light heads may show paint delamination
FDA (Devices) · 2026-06-24
- ModerateHarmonyAIR A-Series surgical light intensity control buttons may detach
FDA (Devices) · 2026-06-24
- ModerateALYON surgical light head intensity control buttons may detach
FDA (Devices) · 2026-06-24
- ModerateDisplay adapters recalled after the wrong configuration file was used
FDA (Devices) · 2026-02-18
- CriticalFrozen whole surti papdi recalled after testing positive for Salmonella
FDA (Devices) · 2025-12-17
Same hazard · cosmetic defect
See all →- LowNilotinib capsules recalled after failing appearance tests at six months
FDA (Drugs) · 2026-03-11
- LowNilotinib 200 mg capsules recalled after failing appearance tests
FDA (Drugs) · 2026-03-11
- LowTrazodone tablets recalled after complaints of a dent on the tablet surface
FDA (Drugs) · 2026-01-07
- LowAneurysm clips recalled due to incorrect paddle coloring
FDA (Devices) · 2024-03-20
- ModerateSteris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration
FDA (Devices) · 2021-01-13