Nanosil Spray Gel — Class II medical device recall Z-1627-2018
Terminated recall by Conseal International, Inc., reported 2018-05-09, distributed in AL, MA, MS. A recent FDA inspection of the firm revealed significant Current Good Manufacturing Practices (cGMP) deficienc
| Recall number | Z-1627-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Conseal International, Inc., Norwood, MA, United States |
| Recall initiated | 2018-04-25 |
| Classified | 2018-05-03 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2019-04-02 |
| Distributed | AL, MA, MS |
| Quantity | 384 |
| Reason classes | cgmp |
| Model numbers | NSP-04 |
Product
Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04 The product is a topical spray used to treat discomfort and other pathological conditions affecting exposed soft tissues of the body caused by microbial infections.
Reason for recall
A recent FDA inspection of the firm revealed significant Current Good Manufacturing Practices (cGMP) deficiencies including lack of data to support products conform to final specifications, and lack of expiration dates on the product being recalled.
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-1627-2018. 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.