Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box — Class II medical device recall Z-0751-2018

Terminated recall by Steris Corporation, reported 2018-03-07, distributed nationwide. On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may

Recall number	`Z-0751-2018`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Steris Corporation, Mentor, OH, United States
Recall initiated	2017-06-15
Classified	2018-02-27
Reported by FDA	2018-03-07
Terminated	2018-07-17
Distributed	Nationwide (US)
Quantity	5
Reason classes	labeling
Lot numbers	`161118A`
Model numbers	`883116`

Product

Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 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 to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

Reason for recall

On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0751-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.