FDA Device recall Z-0312-2025
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517
- FDA Device
- Class I
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class I recall of microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517 by Fhc, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0312-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-10-04 |
| Published | 2024-11-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fhc |
| Distribution | AZ, CA, PA, TN, TX, WA |
Product
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.
Reason
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.
Identifiers
| code_info | Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0312-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.