FDA Enforcement
Class II
Ongoing
PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
Recall: Z-2275-2026
·
Reported June 10, 2026
Enforcement
- Recall Number
- Z-2275-2026
- Event ID
- 98959
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Oculus Technologies of Mexico, S.A. de C.V.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- June 10, 2026
- Initiation Date
- April 27, 2026
- Classification Date
- June 1, 2026
- Address
- Calle Industria Vidriera 81, Industrial Zapopan Norte, Zapopan, N/A, Mexico
Description
PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
Reason
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.
Code Info
UDI:00860009268616 Lot: 25G263
Distribution
US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, KY, MI, MS, NC, NJ, NY, TN, TX, UT, VA.
Quantity
5904 units