FDA Device recall Z-2443-2025
Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdrive…
- FDA Device
- Class II
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class II recall of Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdrive… 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-2443-2025 |
| 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 Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Reason
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Identifiers
| code_info | All kits 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-2443-2025%22
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