Z-1004-2024Class II

Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to...

Name: Z-1004-2024 Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to...
Creator: Olympus Corporation of the Americas
Published: 2023-12-11
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-12-11 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044 on 2023-12-11. FDA classified it as Class II and gives the reason as "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". 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-1004-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-11
Posted: 2024-02-07
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Product code: ETD Tube, Tympanostomy
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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].
Quantity in commerce: 600 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia.
Product codes and lots: UDI: 00821925031913 Lot Number: SM280573

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1004-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1004-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-07

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)