Z-2275-2026Class II

PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

Name: Z-2275-2026 PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
Creator: Oculus Technologies of Mexico, S.A. de C.V.
Published: 2026-04-27
License: https://open.fda.gov/license/

Oculus Technologies of Mexico, S.A de C.V. / initiated 2026-04-27 / Open, Classified / root cause: design

FDA source

Oculus Technologies of Mexico, S.A. de C.V. began a recall of PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050 on 2026-04-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2275-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-27
Posted: 2026-06-01
Recalling firm: Oculus Technologies of Mexico, S.A de C.V.
Product: PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
Product code: FRO Dressing, Wound, Drug
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.
Root cause tag: design
FDA 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 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.
Product codes and lots: UDI:00860009268616 Lot: 25G263

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2275-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2275-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-01

Product code FRO

K172851UnclassifiedMicrocyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc. / cleared 2017-11-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)