Oculus Technologies Of Mexico, S.A. De C.V. recalls PhaseOne Antimicrobial Solution

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.

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

• FDA enforcement recordOfficial FDA database entry for Z-2275-2026
• FDA 510(k) clearance · K172851The device's official FDA premarket clearance record
• FDA device classification · FROOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Oculus Technologies of Mexico, S.A. de C.V.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.