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.
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.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send FHC, Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-0312-2025 — FHC, Inc. FHC, Inc. recalls microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The inten Hello, I own a FHC, Inc. recalls microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode that is covered by recall Z-0312-2025 from FHC, Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
