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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems.
Brand
Acacia Engineered Products LLC
Lot Codes / Batch Numbers
Serial numbers: 07-001 through 07-030.
Products Sold
Serial numbers: 07-001 through 07-030.
Acacia Engineered Products LLC is recalling Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a d due to The firm distributed an unapproved medical device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The firm distributed an unapproved medical device.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026