FDA Medical Device Recalls (openFDA)
InSound Medical, Inc.: InSound Medical, Inc, Lyric in-canal hearing aid.
- Recall number
- Z-1681-2010
- Recalling firm
- InSound Medical, Inc.
- Product
- InSound Medical, Inc, Lyric in-canal hearing aid.
- Status
- Terminated
- Initiated
- 2010-01-19
- Posted
- 2010-05-26
- Terminated
- 2011-08-02
- Reason
- Manufacturing error could result in electrolyte leakage from the product's battery.
- Root cause
- Process design
- Action
- InSound sent to its consignees a "Dear Lyric Provider" letter of explanation on 2/1/2010.
- Quantity
- 2019 units
- Distribution
- Distribution only in US ( nationwide). No foreign consignees involved.
- Lot, serial or model codes
- All devices manufactured between 12/10/2009 and 12/24/2009. Expiration dates 12/10/2010 through 12/24/2010.
- 510(k) numbers
- K081136
- PMA numbers
- not on file
- Product code
- ESD
- Firm FEI
- 3003793405
- Firm city
- Newark
- Firm state
- CA
- 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