FDA Medical Device Recalls (openFDA)
Acacia Engineered Products LLC: Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems.
- Recall number
- Z-2348-2008
- Recalling firm
- Acacia Engineered Products LLC
- Product
- Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems.
- Status
- Terminated
- Initiated
- 2008-07-09
- Posted
- 2008-09-17
- Terminated
- 2010-02-17
- Reason
- The firm distributed an unapproved medical device.
- Root cause
- PMA
- Action
- On July 9, 2008 the firm issued a Device Recall Notification letter to its consignees by letter on July 9, 2008 by US mail. The recall notification was directed to the end users of the units requesting the return of all units. In the event of a non-responding consignee, the firm will make additional efforts to contact the individual via certified return receipt mail or other form of notification requiring a signature. Follow up direct contact through telephone will also be used. If you have any questions contact Eric Johnson at (615) 202-9370.
- Quantity
- 24
- Distribution
- Class II Recall - Nationwide Distribution --- including states of CA, VA, MA and TX.
- Lot, serial or model codes
- Serial numbers: 07-001 through 07-030.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXV
- Firm FEI
- 3006503914
- Firm city
- Franklin
- Firm state
- TN
- 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