FDA Device recall Z-2441-2025
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
- FDA Device
- Class II
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class II recall of Orascoptic Superior Visualization Custom loupes configured with Phantom Frames by Orascoptic Surgical Acuity, citing due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2441-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-03 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Orascoptic Surgical Acuity |
| Distribution | US |
Product
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
Reason
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Identifiers
| code_info | All serial numbers manufactured between June 6, 2023 - May 14, 2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2441-2025%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.