In the agency's Nov 18, 2026 enforcement report · Ongoing
Sheehy VENTILATION TUBE 5PK BUTTON 1.27 FLPL, REF: 1013301, Lot# 0231048279 (GTIN 20763000281636), Lot# 0231048280…
Medtronic Xomed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Xomed, Inc. · 6743 Southpoint Dr N · Jacksonville, FL · 32216-6218
Is this the product you have?
- Sheehy VENTILATION TUBE 5PK BUTTON 1.27 FLPL
- REF
1013301Lot# 0231048279 (GTIN 20763000281636)Lot# 0231048280 (GTIN 20763000281636)
- Lot codes and dates
- UDI-DI20763000281636
- Lots
02310482790231048280
- Amount recalled
- 4000
Where it was sold
Why it was recalled
Ventilation tubes, that provide a passageway for movement of air between the auditory canal and the middle ear, were not subjected to the required sterilization process, which after implantation could cause infection and subsequent inflammation potentially leading to temporary hearing impairment, otorrhea (fluid discharge) and the need for antibiotics.
This product could cause temporary or reversible health problems — stop using it.
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