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Banyan USA, LLC

FDA Regulatory Profile

Banyan USA, LLC has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Nov 12, 2025 · VAI
Latest 510(k)
Sep 22, 2021

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances1Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 12, 2025Hauppauge, NYDevicesVoluntary Action Indicated (VAI)3020737798
Sep 12, 2023Hauppauge, NYDevicesVoluntary Action Indicated (VAI)3020737798

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K211097Banyan USA Surgical Mask Level 3Sep 22, 2021

FDA data resources