Vis-U-All High Temperature Tubing 3"x100' — Class II medical device recall Z-0786-2021
Terminated recall by Steris Corporation, reported 2021-01-13, distributed nationwide. Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing
| Recall number | Z-0786-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2020-12-02 |
| Classified | 2021-01-07 |
| Reported by FDA | 2021-01-13 |
| Terminated | 2022-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 7 cases |
| Reason classes | labeling |
| Lot numbers | 200505A |
| Model numbers | 881031 |
Product
Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031
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
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-0786-2021. 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.