Class IIOngoingZ-0966-2025
Adept Medical Ltd recalls Otological Ventilation Tube - T-Tube 9mm - Silicone
Lack of 510(k) clearance.
- Tympanostomy Tube
- Device Design
Adept Medical LtdJan 29, 2025
The FDA has posted 8 enforcement recalls of tympanostomy tube devices since 2025, none of them Class I (most serious). Most recent report: Jan 29, 2025.
Lack of 510(k) clearance.
Lack of 510(k) clearance.
Lack of 510(k) clearance.
Lack of 510(k) clearance.
Lack of 510(k) clearance.
Lack of 510(k) clearance.
Lack of 510(k) clearance.
Lack of 510(k) clearance.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Tube, Tympanostomy”). Informational only — verify against the FDA before acting.