FDA Medical devices recall ·
PhaseOne Antimicrobial Solution, Model recall
- Recall number
- Z-2275-2026
- Date
- (initiated April 27, 2026)
- Company / brand
- Oculus Technologies of Mexico, S.A. de C.V.
Calle Industria Vidriera 81, Zapopan, Mexico - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5904 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Arizona California Colorado Florida Georgia Illinois Indiana Kentucky Michigan Mississippi North Carolina New Jersey New York Tennessee Texas Utah Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2275-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.