Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
microTargeting Insertion Tube Set Recalled by FHC, Inc. Due to A complaint was received (MDR 3002250546-2024-00003) prompting an...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact FHC, Inc. directly.
Affected Products
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
Quantity: 8 packs of 5ea (40 total)
Why Was This Recalled?
A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging and brain damage.
Where Was This Sold?
This product was distributed to 6 states: AZ, CA, PA, TN, TX, WA
About FHC, Inc.
FHC, Inc. has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report