Recall Z-0707-2025 ยท ETD Tube, Tympanostomy
Olympus Corporation of the Americas
Duravent Silicone Ventilation Tube. Model Number: 240075.
| Date | Dec 19, 2024 (initiated Nov 19, 2024) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932166 | SILICONE TYMPANOSTOMY TUBES Smith & Nephew Richards, Inc., Jul 26, 1993 |