Recall Z-2275-2026— Oculus Technologies of Mexico, S.A. de C.V.

Name: FDA recall Z-2275-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-27

Class II · Ongoing

Class II FDA medical device recall by Oculus Technologies of Mexico, S.A. de C.V., initiated 2026-04-27. It names one FDA 510(k) clearance: K172851. Product: 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..

Recalling firm: Oculus Technologies of Mexico, S.A. de C.V.
Classification: Class II
Status: Ongoing
Initiated: 2026-04-27
Firm location: Zapopan, Mexico

510(k) clearances named in this recall

1 on FDA's record

K172851 — Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc.·cleared 2017-11-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.