Silatrix Oral Gel Polymerized Sucralfate Gel 10% — Class II medical device recall Z-0856-2022
Terminated recall by SA3, LLC, reported 2022-04-13, distributed nationwide. Due to failure of microbial testing for total aerobic microbial count (TAMC).
| Recall number | Z-0856-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SA3, LLC, Los Angeles, CA, United States |
| Recall initiated | 2022-02-21 |
| Classified | 2022-04-04 |
| Reported by FDA | 2022-04-13 |
| Terminated | 2024-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 156 units |
| Reason classes | microbial contamination |
| NDC | 69420-8351-01 |
| Lot numbers | U701SF1 |
Product
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Reason for recall
Due to failure of microbial testing for total aerobic microbial count (TAMC).
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-0856-2022. 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.