Fargo Ortho-K Lens — Class II medical device recall Z-2516-2023
Ongoing recall by PARAGON VISION SCIENCES, Inc, reported 2023-09-13, distributed nationwide. Manufactured lenses are not covered by existing FDA approval
| Recall number | Z-2516-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PARAGON VISION SCIENCES, Inc, Gilbert, AZ, United States |
| Recall initiated | 2023-06-26 |
| Classified | 2023-09-05 |
| Reported by FDA | 2023-09-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, JP, VN |
| Quantity | 18,820 lenses |
| Lot numbers | B22208 |
Product
Fargo Ortho-K Lens
Reason for recall
Manufactured lenses are not covered by existing FDA approval
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-2516-2023. 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.