CLASS II Device recall · Reported 13 Jan 2021 · FDA Enforcement Report

Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches recalled

Steris is recalling Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per, distributed nationwide in the US. The recall was initiated on 2 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 200536A

Quantity recalled7 cases

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0797-2021
FDA event ID: 86942
Recalling firm: Steris, Mentor, OH
Classification: Class II
Status: Terminated
Recall initiated: 2 Dec 2020
FDA classified: 7 Jan 2021
Reported: 13 Jan 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

2 Dec 2020	Recall initiated by company
7 Jan 2021	Classified by FDA	+36 days
13 Jan 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884515

Where it was distributed

Nationwide Foreign:

Nationwide

Questions about this recall

Is Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per recalled?

Yes. Steris recalled Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per on 2 Dec 2020. The recall is Class II and its status is Terminated. Recall number Z-0797-2021.

Why was it recalled?

Which lots are affected?

Lot Number: 200536A

Where was it sold?

Nationwide Foreign:

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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