Lower risk Medical device recall · FDA · Published December 2, 2020

Steris Vis-U-All Pouches: Purple Ink Bleed Risk

Steris recalls 200-pouch heat seal pouches with purple ink that may bleed after steam processing, causing cosmetic defects and ink transfer to devices. Affected units have model 883713 and lot numbers 200425A or 200625A.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0792-2021Medical device Steris ›

Lower-risk recall

Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch

Take action

Contact the company

Recalling firmSteris Corporation5960 Heisley Rd · Mentor, OH 44060-1834

✎ GovInfoNow plain-language explainer

Steris is recalling heat seal pouches that may bleed purple ink after steam processing, potentially transferring ink to devices inside. This could cause cosmetic issues and ink residue on equipment, but does not pose a safety risk. Read more at govinfonow.com/recall/63730-steris-vis-u-all-pouches-purple-ink-bleed-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63730-steris-vis-u-all-pouches-purple-ink-bleed-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0792-2021

Cite this page

“Steris Vis-U-All Pouches: Purple Ink Bleed Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63730-steris-vis-u-all-pouches-purple-ink-bleed-risk. Based on FDA recall #Z-0792-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0792-2021%22&limit=1).

The FDA announced on December 2, 2020, that Steris Corporation voluntarily recalled Vis-U-All High Temp Heat Seal Pouches due to a hazard involving purple ink migration. This defect can cause cosmetic issues and potentially transfer ink onto devices inside the pouch.

How to tell if you have it

Brand: Steris
Product: Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch
Model Number: 883713
Lot Numbers: 200425A, 200625A
Quantity: 31 cases

The hazard

Purple ink on the outside label of the pouches may migrate following steam processing. This can cause cosmetic defects and, in some instances, transfer ink onto the devices contained within the pouch.

Context

GovInfoNow's records show Steris Corporation has 31 other recalls on record since June 15, 2017. Other recent recalls include a September 23, 2026 issue with the HexaVue Focus Integration System Software and an August 31, 2026 recall of VERIFY Dual Species Self-Contained Biological Indicators. A May 15, 2026 recall involved HarmonyAIR A-Series Surgical Lights where buttons may detach.

How to tell if you have this one

Check for model number 883713 and lot numbers 200425A or 200625A on the pouch packaging. The pouches come in sets of 200 per box and 5 boxes per case.

Brand
Steris
Category
Medical device

FDA recall event · 14 products

All 14 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide Foreign:

Recall number	Product, codes & lots	Quantity
Z-0786-2021	Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031; Lot Number: 200505A	7 cases
Z-0787-2021	Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881041; Lot Number: 200406A	65 units
Z-0788-2021	Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881061; Lot Number: 200407A, 200707A	98 cases
Z-0789-2021	Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091; Lot Number: 200408A	197 cases
Z-0790-2021	Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883411; Lot Number: 200421A, 200521A	53 cases
Z-0791-2021	Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610; Lot Number: 200424A, 200524A	54 cases
Z-0792-2021	Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713; Lot Number: 200425A, 200625A	31 cases
Z-0793-2021	Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039; Lot Number: 200428A, 200628A	170 cases
Z-0794-2021	Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118; Lot Number: 200430A	589 cases
Z-0795-2021	Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884411; Lot Number: 200434A	43 cases
Z-0796-2021	Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884510; Lot Number: 200435A, 200635A	229 cases
Z-0797-2021	Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884515; Lot Number: 200536A	7 cases
Z-0798-2021	Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884713; Lot Number: 200437A, 200637A	201 cases
Z-0799-2021	Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884816; Lot Number: 200438A	46 cases

Based on the official FDA remedy

What to do — step by step

Check Pouch Details
Verify model number 883713 and lot numbers 200425A or 200625A on the pouch packaging.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide Foreign:” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

Dec 2, 2020Firm started the recall
Jan 7, 2021FDA classified it Class II
Jan 13, 2021Published in FDA’s Enforcement Report
Jun 21, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63730-steris-vis-u-all-pouches-purple-ink-bleed-risk">Steris Vis-U-All Pouches: Purple Ink Bleed Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0792-2021 (December 2, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0792-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.