CLASS II ONGOING Device recall · Reported 25 Dec 2024 · FDA Enforcement Report

Duravent Silicone Ventilation Tube recalled

Olympus Corporation of the Americas is recalling Duravent Silicone Ventilation Tube, distributed in 18 states. The recall was initiated on 19 Nov 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 240075. UDI: 00521925031883 (17)331015 (10)SM405666, Lot Number: SM405666. UDI: 00521925031883 (17)331015 (10)JB362646, Lot Number: JB362646.

Quantity recalled984 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0707-2025
FDA event ID: 95716
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 19 Nov 2024
FDA classified: 19 Dec 2024
Reported: 25 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

19 Nov 2024	Recall initiated by company
19 Dec 2024	Classified by FDA	+30 days
25 Dec 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Duravent Silicone Ventilation Tube. Model Number: 240075.

Where it was distributed

AL, AZ, CA, IL, KY, MD, MN, MO, NC, ND, NY, OK, PA, SC, TN, TX, WA, WI. International distribution to Australia, Canada, Germany.

Alabama Arizona California Illinois Kentucky Maryland Minnesota Missouri North Carolina North Dakota New York Oklahoma Pennsylvania South Carolina Tennessee Texas Washington Wisconsin

Questions about this recall

Why was it 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.

Which lots are affected?

Model Number: 240075. UDI: 00521925031883 (17)331015 (10)SM405666, Lot Number: SM405666. UDI: 00521925031883 (17)331015 (10)JB362646, Lot Number: JB362646.

Where was it sold?

AL, AZ, CA, IL, KY, MD, MN, MO, NC, ND, NY, OK, PA, SC, TN, TX, WA, WI. International distribution to Australia, Canada, Germany.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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