Duravent Silicone Ventilation Tube. Model Number: 240075 recallZ-0707-2025 · Olympus Corporation of the Americas · initiated Nov 19, 2024
Class II Open, Classified All recalls posted in December 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.
FDA root cause category: Process control
What the company is doing
Olympus notified consignees on 11/19/2024 via Courier, 2-day delivery. Consignees were instructed to examine inventory for affected devices, quarantine any affected devices on hand, arrange for return of those affected units and acknowledge receipt of the customer letter through the web portal.
Recall details
- Recall number
- Z-0707-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Nov 19, 2024
- Posted by the FDA
- Dec 19, 2024
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 984 units
- Product code
- ETD
- FDA submissions
- K932166
- Distribution
- AL, AZ, CA, IL, KY, MD, MN, MO, NC, ND, NY, OK, PA, SC, TN, TX, WA, WI. International distribution to Australia, Canada, Germany.
Product description
Duravent Silicone Ventilation Tube. Model Number: 240075.
Code information (models, lots, serial numbers)
Model Number: 240075. UDI: 00521925031883 (17)331015 (10)SM405666, Lot Number: SM405666. UDI: 00521925031883 (17)331015 (10)JB362646, Lot Number: JB362646.
Other devices under the same FDA submission
2 devices cleared under K932166 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Gyrus ACMI 240044Gyrus ACMI, LLC · TUBE, TYMPANOSTOMY1 recall0 reports
- Gyrus ACMI 245775Gyrus ACMI, LLC · Tube, Tympanostomy9 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page