FDA Medical devices recall ·
microTargeting Insertion Tube Set, P/N 66-IT-05P recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0312-2025
- Date
- (initiated October 4, 2024)
- Company / brand
- FHC, Inc.
1201 Main St, Bowdoin, ME, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 8 packs of 5ea (40 total)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517
Distribution
Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.
States: Arizona California Pennsylvania Tennessee Texas Washington
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0312-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.