FDA recall Z-2275-2026

Oculus Technologies of Mexico, S.A. de C.V. · Class II · device

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.

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.

Key facts

Status
Ongoing
Initiation date
2026-04-27
Report date
2026-06-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Zapopan, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2275-2026