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FDA DevicesClass II

PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

Veröffentlicht: 10. Juni 2026Rückruf-ID: Z-2275-2026Kategorie: MedizinprodukteLand: Vereinigte Staaten
US
Medical DeviceFDA DevicesUSUS

PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

Recalling Firm: Oculus Technologies of Mexico, S.A. de C.V.

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Mitteilung übersetzenTranslate notice text, hazard warnings, and descriptions into any supported language.

Grund für den Rückruf / Gefahr

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.

Produktbeschreibung & Identifikation

PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

Additional Source Details

FieldValue
CityZapopan
Event id98959
Address 1Calle Industria Vidriera 81
Address 2Industrial Zapopan Norte
Code infoUDI:00860009268616 Lot: 25G263
Postal codeN/A
Report date20260610
Product typeDevices
Product quantity5904 units
Reason for recallThe 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.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260427
Center classification date20260601

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Übersicht

  • Rückrufendes UnternehmenOculus Technologies of Mexico, S.A. de C.V.
  • StatusOngoing
  • RisikostufeClass II
  • DistributionUS Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, KY, MI, MS, NC, NJ, NY, TN, TX, UT, VA.
Recall Hazard Severity
High Alert (Class I)
Offizielle Behördenwarnung

📢 Warnung teilen

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🚨 SAFETY ALERT: Oculus Technologies of Mexico, S.A. de C.V. - PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

Check if your household is affected:
https://therecallfile.com/de/recalls/phaseone-antimicrobial-solution-model-catalog-number-15050/FDA-Z-2275-2026
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