PhaseOne Antimicrobial Solution — Class II medical device recall Z-2275-2026
Ongoing recall by Oculus Technologies of Mexico, S.A. de C.V., reported 2026-06-10, distributed nationwide. The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. T
| Recall number | Z-2275-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Oculus Technologies of Mexico, S.A. de C.V., Zapopan, Mexico |
| Recall initiated | 2026-04-27 |
| Classified | 2026-06-01 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 5,904 units |
| UPC / GTIN / UDI-DI | 00860009268616 |
| Lot numbers | 25G263 |
| Model numbers | 15050 |
Product
PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
Reason for recall
The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in the solution during use.
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-2275-2026. 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.