Oculus Technologies of Mexico, S.A. de C.V.: PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Oculus Technologies of Mexico, S.A. de C.V.
- Product
- PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, KY, MI, MS, NC, NJ, NY, TN, TX, UT, VA.
- Recall initiated
- 2026-04-27
- Code info
- UDI:00860009268616 Lot: 25G263
- Product quantity
- 5904 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Zapopan
- Country
- Mexico
- Event id
- 98959
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