FDA Device recall Z-1118-2022
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
- FDA Device
- Class II
- terminated
- Published 2022-06-01
On 2022-06-01 the FDA classified a Class II recall of 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 by Steris, citing product not approved for release for US distribution.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1118-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-22 |
| Published | 2022-06-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Steris |
| Distribution | US |
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
Product not approved for release for US distribution
Identifiers
| code_info | Lot Number: 202108 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1118-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.