Recall Z-2275-2026 ยท FRO Dressing, Wound, Drug
Oculus Technologies of Mexico, S.A. de C.V.
PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
| Date | Jun 1, 2026 (initiated Apr 27, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 app |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172851 | Microcyn Plus Antimicrobial Wound Care Solution Sonoma Pharmaceuticals, Inc., Nov 15, 2017 |