FHC, Inc. recalls microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode…

Recall date

October 4, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0312-2025

FDA classification

Class I

Brand / firm

FHC, Inc.

Sold / distributed

Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.

Why it was 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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.