Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5 — Class II medical device recall Z-1118-2022
Terminated recall by Steris Corporation, reported 2022-06-01, distributed nationwide. Product not approved for release for US distribution
| Recall number | Z-1118-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2022-03-22 |
| Classified | 2022-05-20 |
| Reported by FDA | 2022-06-01 |
| Terminated | 2024-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 103 cases |
| Reason classes | unapproved product |
| Lot numbers | 202108 |
| Model numbers | ENC100 |
Product
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100
Reason for recall
Product not approved for release for US distribution
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-1118-2022. 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.