FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Duravent Silicone Ventilation Tube. Model Number: 240075.
- Recall number
- Z-0707-2025
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Duravent Silicone Ventilation Tube. Model Number: 240075.
- Status
- Open, Classified
- Initiated
- 2024-11-19
- Posted
- 2024-12-19
- Terminated
- not on file
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Model Number: 240075. UDI: 00521925031883 (17)331015 (10)SM405666, Lot Number: SM405666. UDI: 00521925031883 (17)331015 (10)JB362646, Lot Number: JB362646.
- 510(k) numbers
- ["K932166"]
- PMA numbers
- not on file
- Product code
- ETD
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28