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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

TOMSCOUT

Issued · Posted by FDA

FDA published a close-out letter on Apr 7, 2026. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Per your firm’s website: “Binders help reduce gender dysphoria”

Passage 2

Per your firm’s website: "Using a chest binder to flatten the chest can help alleviate gender dysphoria”

Passage 3

Per your firm’s website: "binding alleviates distress associated with gender dysphoria”

Passage 4

Our records indicate that you have not registered or listed these devices for fiscal year 2026.