FDA Class II Recall: PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050 by Oculus Technologies of Mexico, S.A. de C.V.

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Oculus Technologies of Mexico, S.A. de C.V. and the affected product is described in FDA's record as: PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050. FDA's stated reason for the recall is: 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 (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2275-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050 -- and the recall number Z-2275-2026. If it matches, stop using or distributing it and contact Oculus Technologies of Mexico, S.A. de C.V. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Oculus Technologies of Mexico, S.A. de C.V.’s FDA history

Argus HQ has recorded 1 total FDA action tied to Oculus Technologies of Mexico, S.A. de C.V.: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050) and recall number Z-2275-2026, then follow Oculus Technologies of Mexico, S.A. de C.V.'s recall instructions.

Has Oculus Technologies of Mexico, S.A. de C.V. had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for Oculus Technologies of Mexico, S.A. de C.V. so far. Argus ingests new FDA enforcement records daily.

What is the FDA recall number for this event?

FDA recall number Z-2275-2026.

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