Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone… recallZ-1004-2024 · Olympus Corporation of the Americas · initiated Dec 11, 2023
Open, Classified
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
The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot
FDA root cause category: Employee error
What the company is doing
Olympus (Gyrus ACMI, Inc.) issued Urgent Medical Device Removal letter on 12/11/23. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory and identify any products of the model and lot subject to this action. Please check all areas of your facility to determine if any of these devices remain in inventory. Quarantine and cease use of the affected model/lot. 2. Please contact Olympus Customer Service at 1-800-848-9024, option 2, with the quantity and model of affected devices. Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall. b. Enter the recall number "0436 c. Complete the form as instructed. 4. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at [email protected].
Recall details
- Recall number
- Z-1004-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 11, 2023
- Posted by the FDA
- Feb 7, 2024
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 600 units
- Product code
- ETD
- FDA submissions
- K932166
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia.
Product description
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Code information (models, lots, serial numbers)
UDI: 00821925031913 Lot Number: SM280573
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Gyrus ACMI 240044Gyrus ACMI, LLC · TUBE, TYMPANOSTOMY1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K932166 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- 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 16, 2026. Text above is shown as published by the FDA.
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