Recall Ledger

PhaseOne Antimicrobial Solution recall (Oculus Technologies of Mexico, S.A. de C.V.)

Medical deviceClass IIOngoing

Summary: Oculus Technologies of Mexico, S.A. de C.V. is recalling 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.

What is being recalled

PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

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 named: Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Michigan, Mississippi, North Carolina, New Jersey, New York, Tennessee, Texas, Utah, Virginia)

How to tell if yours is affected

UDI:00860009268616 Lot: 25G263

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2275-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedApril 27, 2026
ReportedJune 10, 2026
CompanyOculus Technologies of Mexico, S.A. de C.V.
Company locationZapopan, Mexico
Initiated byVoluntary: Firm initiated
Quantity5904 units

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