Phoroptor VRx Digital Refraction System Model Numbers: 16241 — Class II medical device recall Z-1500-2025
Ongoing recall by Reichert, Inc., reported 2025-04-09, distributed nationwide. The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
| Recall number | Z-1500-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Reichert, Inc., Depew, NY, United States |
| Recall initiated | 2025-02-28 |
| Classified | 2025-03-31 |
| Reported by FDA | 2025-04-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BO, CA, CH, DE, DK, FR, GB, HK, IL, IN, IT, MA, NL, NO, QA, SA, SG, SK, TH |
| Quantity | 122 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00812559011716 |
| Model numbers | 00812559011716, 16241 |
Product
Phoroptor VRx Digital Refraction System Model Numbers: 16241
Reason for recall
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
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-1500-2025. 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.