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PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050 recallZ-2275-2026 · Oculus Technologies of Mexico, S.A. de C.V. · initiated Apr 27, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Oculus Technologies of Mexico, S.A. de C.V. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Component design/selection

What the company is doing

A MEDICAL DEVICE RECALL notification letter dated 4/27/26 was sent to customers. How to recognize that the device may fail The device may fail if the sprayer component shows internal corrosion, which can affect the appearance of the solution during use. Because the product is packaged in an amber glass bottle, it may be difficult to clearly see changes in the solution inside the container. Therefore, the issue is most likely to be identified during dispensing. Users may recognize this issue by observing a change in color of the solution when sprayed (for example, a light brown or tea-like appearance) or by noticing discoloration within the sprayer mechanism. # Actions to be Taken by the Customer/User As a precaution, any sprayers included with PhaseOne 50 ml bottles should not be used and should be discarded. The solution remains safe and effective for its intended use when it has not been in contact with the sprayer. PhaseOne Health, LLC should inform its customers that product units that have not been assembled with the sprayer may continue to be used safely by carefully pouring the solution directly from the bottle. Product units that have already been assembled with the sprayer should not be used in this configuration and should be removed from use and retained by PhaseOne Health, LLC. Product returned by customers should be held in a designated area and not redistributed or disposed of until further instructions are provided. PhaseOne Health, LLC is requested to retain all returned product and affected inventory at its facility. At this time, Oculus Technologies of Mexico, S.A. de C.V. is not requesting return of product to the manufacturing site. Disposition of returned product, including destruction, will be performed only after alignment with and, if required, approval from the FDA Recall Coordinator. These actions are temporary and are being implemented while a long-term corrective solution is completed. An updated sprayer design intended to prevent

Recall details

Recall number
Z-2275-2026
Status
Open, Classified
Initiated by the company
Apr 27, 2026
Posted by the FDA
Jun 1, 2026
Recalling firm
Oculus Technologies of Mexico, S.A. de C.V.
Quantity
5904 units
Product code
FRO
FDA submissions
K172851
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.

Product description

PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

Code information (models, lots, serial numbers)

UDI:00860009268616 Lot: 25G263

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page