FDA Device recall Z-1501-2025
Phoroptor VRx Digital Refraction System Model Numbers: 16242
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of Phoroptor VRx Digital Refraction System Model Numbers: 16242 by Reichert, citing the head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1501-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-28 |
| Published | 2025-04-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Reichert |
| Distribution | US |
Product
Phoroptor VRx Digital Refraction System Model Numbers: 16242
Reason
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Identifiers
| code_info | Model Numbers: 16242; UDI-DI: 00812559011730; Serial Numbers: TBD; Note: The majority of units within the scope of the…Model Numbers: 16242; UDI-DI: 00812559011730; Serial Numbers: TBD; Note: The majority of units within the scope of the planned recall are older devices which do not have a UDI on the label. |
|---|
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-1501-2025%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.