PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
Summary
The FDA issued a Class II for PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050 by Oculus Technologies of Mexico, S.A. de C.V.. Reason: The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material inco.
Details
Source
Device Recall
External ID
Z-2275-2026
Action Date
2026-06-10
Status
Ongoing
Category
device
Product Description
PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
Lot/Code Info: UDI:00860009268616 Lot: 25G263
Quantity Affected: 5904 units
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-27
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 169 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Oculus Technologies of Mexico, S.A. de C.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Oculus Technologies of Mexico, S.A. de C.V. have FDA actions?
This is the only FDA action we have on record for Oculus Technologies of Mexico, S.A. de C.V. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2275-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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