Class 2 Device Recall PhaseOne

• Date Initiated by Firm: April 27, 2026
• Date Posted: June 01, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2275-2026
• Recall Event ID: 98959
• 510(K)Number: K172851
• Product Classification: Dressing, wound, drug - Product Code FRO
• Product: PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
• Code Information: UDI:00860009268616 Lot: 25G263
• FEI Number: 3007244484
• Recalling Firm/ Manufacturer: Oculus Technologies of Mexico, S.A. de C.V.; Calle Industria Vidriera 81; Industrial Zapopan Norte; Zapopan Mexico
• Manufacturer 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.
• FDA Determined Cause: Component design/selection
• Action: 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
• Quantity in Commerce: 5904 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRO