Z-0707-2025Class II

Duravent Silicone Ventilation Tube. Model Number: 240075

Name: Z-0707-2025 Duravent Silicone Ventilation Tube. Model Number: 240075
Creator: Olympus Corporation of the Americas
Published: 2024-11-19
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-11-19 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of Duravent Silicone Ventilation Tube. Model Number: 240075 on 2024-11-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0707-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-19
Posted: 2024-12-19
Recalling firm: OLYMPUS Corporation of the Americas
Product: Duravent Silicone Ventilation Tube. Model Number: 240075.
Product code: ETD Tube, Tympanostomy
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 984 units
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 codes and lots: Model Number: 240075. UDI: 00521925031883 (17)331015 (10)SM405666, Lot Number: SM405666. UDI: 00521925031883 (17)331015 (10)JB362646, Lot Number: JB362646.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0707-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0707-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-19

Product code ETD

K932166Class IISilicone Tympanostomy TubesSmith & Nephew Richards, Inc. / cleared 1993-07-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)