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My DashboardInspection TrackerWarning Letters3B Medical, Inc. dba Reach Health, Inc.

All Warning Letters

3B Medical, Inc. dba Reach Health, Inc.

Warning LetterOpen

3B Medical, Inc. dba Reach Health, Inc., 5475 Rings Road Dublin , OH 43017 United States, (b)(4)Issued May 20, 2026Center for Devices and Radiological Health

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations10

Issue DateMay 20, 2026

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: 3B Medical, Inc. dba Reach Health, Inc.
Location: 3B Medical, Inc. dba Reach Health, Inc., 5475 Rings Road Dublin , OH 43017 United States, (b)(4)
FEI Number: N/A
Country: United States
Issue Date: May 20, 2026
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Subject

CGMP/QSR/Medical Devices/Adulterated

3B Medical, Inc. dba Reach Health, Inc. FDA Warning Letter, May 20, 2026