FDA Medical Device Recalls (openFDA)
Oculus Technologies of Mexico, S.A. de C.V.: PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
- Recall number
- Z-2275-2026
- Recalling firm
- Oculus Technologies of Mexico, S.A. de C.V.
- Product
- PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
- Status
- Open, Classified
- Initiated
- 2026-04-27
- Posted
- 2026-06-01
- Terminated
- not on file
- 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 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
- 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.
- Lot, serial or model codes
- UDI:00860009268616 Lot: 25G263
- 510(k) numbers
- ["K172851"]
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 3007244484
- Firm city
- Zapopan
- Firm state
- not on file
- Firm country
- Mexico
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28