Orascoptic Superior Visualization Dragonfly Essentials Kit — Class II medical device recall Z-2442-2025
Ongoing recall by Orascoptic Surgical Acuity, reported 2025-09-03, distributed nationwide. Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
| Recall number | Z-2442-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orascoptic Surgical Acuity, Orange, CA, United States |
| Recall initiated | 2025-07-03 |
| Classified | 2025-08-26 |
| Reported by FDA | 2025-09-03 |
| Distributed | Nationwide (US) |
| Quantity | 32 kits |
Product
Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Reason for recall
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
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-2442-2025. 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.