FDA Medical Device Recalls (openFDA)
FHC, Inc.: 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.
- Recall number
- Z-0312-2025
- 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.
- Status
- Open, Classified
- Initiated
- 2024-10-04
- Posted
- 2024-11-08
- Terminated
- not on file
- 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.
- 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 kmoeykens@fh-co.com or by telephone at 207-666-5425.
- Quantity
- 8 packs of 5ea (40 total)
- Distribution
- Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.
- Lot, serial or model codes
- Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517
- 510(k) numbers
- ["K011775"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 3002250546
- Firm city
- Bowdoin
- Firm state
- ME
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28