Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration
Steris is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink may migrate onto the pouch exterior or the medical devices inside after steam processing.
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 identifies the issue as causing 'cosmetic defects' and ink transference, which aligns with the rubric criteria for cosmetic defects and packaging-only problems.
Plain-English summary
Steris Corporation is recalling Vis-U-All High Temp 3"x8" Heat Seal Pouches (Model # 883038, Lot # 161115A). The recall involves 19 units distributed nationwide in the United States.
The recall was initiated because 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, transfer ink onto the medical devices contained within the pouch.
Healthcare providers who have purchased these specific pouches should stop using them and contact Steris Corporation for further instructions.
The recalled product
- Product
- Vis-U-All High Temp 3"x8" 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
- Affected units
- 19
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# 883038 Lot# 161115A
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 →- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
Same hazard · cosmetic defect
See all →- ModerateICU Medical Recalls Oncology Sets with Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
- 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
Similar recalls
- ModerateSteris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration
FDA (Devices) · 2021-01-13
- LowSteris Vis-U-All Heat Seal Pouches Recalled for Ink Migration
FDA (Devices) · 2021-01-13
- LowSteris Vis-U-All Pouches Recalled for Ink Migration
FDA (Devices) · 2021-01-13
- LowSteris Recalls Vis-U-All Pouches Due to Ink Migration
FDA (Devices) · 2021-01-13
- LowSteris Recalls Vis-U-All Pouches Due to Ink Migration Defects
FDA (Devices) · 2021-01-13
- LowSteris Vis-U-All Pouches Recalled for Ink Migration on Exterior Labels
FDA (Devices) · 2021-01-13