Class II U.S. Food and Drug Administration

Oculus Technologies of Mexico, S.A. de C.V. PhaseOne Antimicrobial Solution, Model/ recall: The recall is being conducted due to corrosion of the internal metallic

Recall published 5 months ago

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.

The hazard: Lead or heavy metal content

Lead is the reason for this notice. The important thing is removing the source and asking about a blood test, in that order.

What the notice says: 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.

Why it matters: The product exceeds the federal limit on lead or another heavy metal. Lead harms the developing brain, and the damage builds quietly from small repeated exposures rather than arriving as a single dramatic poisoning.

Symptoms and when to call a doctor

The CDC states there is no known safe level of lead in a child’s blood, and that most children with elevated levels show no symptoms at all. That is why a blood lead test, not a symptom check, is the way to find out. Ask your paediatrician about testing if a child has handled, mouthed or worn the product regularly. Where symptoms do appear they are non-specific — irritability, poor appetite, stomach pain, tiredness, constipation or a drop in attention and learning.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2275-2026
Published
June 10, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Oculus Technologies of Mexico, S.A. de C.V.
Product type
Medical devices
Units affected
5904 units
Distribution
Nationwide
Made in
Mexico
Lot / code info
UDI:00860009268616 Lot: 25G263
UPC codes
00860009268616

Products covered by this recall

PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00860009268616

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 25G263 — 5904 units

Model or item number

On the rating label, the box or the instruction sheet.

  • 15050 — UDI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Lead

Oculus Technologies of Mexico, S.A. de C.V. — Lead is the reason for this notice. The important thing is removing the source and asking about a blood test, in that order.

  1. Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.
  2. Do not sand, scrape, burn or break the item up; that turns a contained hazard into dust you can breathe.
  3. Follow the remedy on this page — lead recalls almost always carry a full refund.
  4. Wash the hands of anyone who has been handling it, and wipe down the surfaces it has been sitting on.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • A replacement is usually the current model, not the recalled one. Confirm the replacement is not itself under recall.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.

Company contact: Oculus Technologies of Mexico, S.A. de C.V. — Calle Industria Vidriera 81, Zapopan

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Oculus Technologies of Mexico, S.A. de C.V. medical devices 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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00860009268616; lot code 25G263 — 5904 units; model number 15050 — UDI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.

Can I get my money back?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

Where was the recalled product sold?

It was distributed nationwide.

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