Bowdoin, ME, United States
FHC, Inc. recalls
3 recalls recorded since 2018, most recently on 4 October 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 4 October 2024
- 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.
- Distribution
- Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0312-2025
- 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.
Terminated Class II Medical devices
- Recall started
- 17 June 2020
- Terminated
- 2 November 2020
- Reason
- An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of interference with proper performance of the Guideline 5 Main Processing Unit, if an ESD event (greater than 6kV) were to occur.
- Distribution
- US Nationwide distribution including in the states of CA, NC, TN, TX, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2540-2020
- FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue N
Terminated Class II Medical devices
- Recall started
- 10 May 2018
- Terminated
- 30 April 2019
- Reason
- The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
- Distribution
- The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreig
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2349-2018, Z-2351-2018, Z-2345-2018, Z-2347-2018, Z-2359-2018, Z-2346-2018, Z-2358-2018, Z-2353-2018, Z-2356-2018, Z-2357-2018, Z-2354-2018, Z-2348-2018 and 3 more
- microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
- microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
- microTargeting" Drive System, Product Number MT-DS
- microTargeting" Drive System, Product Number 66-ZD-MD
- microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
- microTargeting" Drive System, Product Number MT-DS-01
- microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002
- microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB
- and 7 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.