Class 2 Device Recall Ventilation (Tympanostomy) Tubes

• Date Initiated by Firm: September 24, 2026
• Date Posted: November 06, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0387-2027
• Recall Event ID: 100076
• 510(K)Number: K151067
• Product Classification: Tube, tympanostomy - Product Code ETD
• Product: Sheehy VENTILATION TUBE 5PK BUTTON 1.27 FLPL, REF: 1013301, Lot# 0231048279 (GTIN 20763000281636), Lot# 0231048280 (GTIN 20763000281636).
• Code Information: UDI-DI: 20763000281636. Lots: 0231048279, 0231048280
• FEI Number: 1045254
• Recalling Firm/ Manufacturer: Medtronic Xomed, Inc.; 6743 Southpoint Dr N; Jacksonville FL 32216-6218
• For Additional Information Contact: Marie Gentile; 904-296-9600
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process control
• Action: On 9/24/2026, recall notices were mailed and emailed to customers asking them to do the following: For patients who currently have implanted affected devices, as a precautionary measure, should continue to be monitored in accordance with standard clinical practices. 1) Identify, segregate, quarantine, and stop use of any affected products within your inventory. 2) Return affected unused product in your inventory to firm; see response form. 3) Share this communication within your organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action. Maintain a copy of this letter for your records. 4) Complete and return the Customer Confirmation Form via email to neuro.quality@medtronic.com For questions, contact your firm Representative or Customer Service at 800-874-5797 rs.jaxcustomerservice@medtronic.com
• Quantity in Commerce: 4000
• Distribution: Worldwide - US Nationwide distribution including in the states of NY, AL, VA, MI, AZ, WA, TX, MA, IL, ME, NM, CA, IN, NC, OH, MO, MN, NH, IA, NV, GA, PA, FL, TN, WV, SC, OK, NE, OR, SD, AK, LA, CO, WI, MD, KS, UT, ID, WY, NJ and the countries of Canada, Australia, New Zealand, Hong Kong.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = ETD