FHC, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0312-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: October 4, 2024

Date Posted: November 20, 2024

Recall Number: Z-0312-2025

Event ID: 95479

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 8 packs of 5ea (40 total)

Code Information:

Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated