Z-0312-2025Class I

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

Name: Z-0312-2025 microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a...
Creator: FHC, Inc.
Published: 2024-10-04
License: https://open.fda.gov/license/

FHC, Inc. / initiated 2024-10-04 / Open, Classified

FDA source

FHC, Inc. began a recall of 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... on 2024-10-04. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0312-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-10-04
Posted: 2024-11-08
Recalling firm: FHC, Inc.
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.
Product code: HAW Neurological Stereotaxic Instrument
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.
FDA root cause: Process change control
Action: On October 4, 2024, the firm notified affected consignees via Urgent Medical Device Recall letters. Customers were instructed to immediately identify and quarantine all affected product. The firm will contact customers and issue an RMA to return affected product and issue a replacement by 10/11/24. Customers should not use the product in the interim. Should you have any further questions regarding this matter you may contact the firm by email at [email protected] or by telephone at 207-666-5425.
Quantity in commerce: 8 packs of 5ea (40 total)
Distribution: Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.
Product codes and lots: Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0312-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0312-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-08

Product code HAW

K011775Class IIMicro Targeting Drive SystemFHC, Inc. / cleared 2001-08-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)