FDA Medical Device Recalls (openFDA)
Gyrus Acmi, Incorporated: PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
- Recall number
- Z-0411-2013
- Recalling firm
- Gyrus Acmi, Incorporated
- Product
- PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
- Status
- Terminated
- Initiated
- 2012-10-17
- Posted
- 2012-11-20
- Terminated
- 2013-04-09
- Reason
- One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.
- Root cause
- Material/Component Contamination
- Action
- The firm, Olympus, sent an "URGENT: Medical Device Recall" letter dated October 15, 2012 to their consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to inspect their stock to confirm if any of the affected lot of product remains in their possession; immediately cease any further use of any affected product; remove it from their stockroom and quarantine it until it is shipped back to Gyrus ACMI, Inc.; call their Gyrus ACMI customer service representative (800-773-4301) to obtain a Returned Goods Authorization and promptly return any affected product to Gyrus ACMI, Inc., 2925 Appling Rd, Bartlett, TN 38133., and complete and return the RECALL REPLY FORM to Attn: Regulatory Affairs via fax to: (508) 804-2624, even if there is no affected stock left at your facility. If you have any questions, contact the customer service at 800-773-4301.
- Quantity
- 10 boxes/60 units
- Distribution
- Worldwide distribution: USA state of Kansas and country of Korea.
- Lot, serial or model codes
- JC470075
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ETD
- Firm FEI
- 3003790304
- Firm city
- Southborough
- Firm state
- MA
- 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