CLASS II ONGOING Device recall · Reported 10 Jun 2026 · FDA Enforcement Report

PhaseOne Antimicrobial Solution recalled by Oculus Technologies of

Oculus Technologies of Mexico, S.A. de C.V is recalling PhaseOne Antimicrobial Solution, distributed nationwide in the US. The recall was initiated on 27 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI:00860009268616 Lot: 25G263

Quantity recalled5904 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2275-2026
FDA event ID: 98959
Recalling firm: Oculus Technologies of Mexico, S.A. de C.V, Zapopan
Classification: Class II
Status: Ongoing
Recall initiated: 27 Apr 2026
FDA classified: 1 Jun 2026
Reported: 10 Jun 2026
Type: Voluntary: Firm initiated
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

27 Apr 2026	Recall initiated by company
1 Jun 2026	Classified by FDA	+35 days
10 Jun 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

Where it was distributed

US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, KY, MI, MS, NC, NJ, NY, TN, TX, UT, VA.

Nationwide Arizona California Colorado Florida Georgia Illinois Indiana Kentucky Michigan Mississippi North Carolina New Jersey New York Tennessee Texas Utah Virginia

Questions about this recall

Is PhaseOne Antimicrobial Solution recalled?

Yes. Oculus Technologies of Mexico, S.A. de C.V recalled PhaseOne Antimicrobial Solution on 27 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2275-2026.

Why was it recalled?

Which lots are affected?

UDI:00860009268616 Lot: 25G263

Where was it 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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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