The Recall Desk

Manufacturer

FHC, Inc.

17 recalls in our database name FHC, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
17
Critical
0
Severe
14
Most recent
2024-11-20

Of the 17 recalls from FHC, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (82%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–17 of 17

  • SevereFDA (Devices)·Z-0312-2025·2024-11-20

    FHC microTargeting Insertion Tube Set Recalled for Spacer Defect

    FHC, Inc. recalls microTargeting Insertion Tube Set Lot 244517, affecting 40 units distributed domestically. The oversized spacer tube component risks intracranial hemorrhaging during neurosurgical procedures.

    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.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2540-2020·2020-07-15

    FHC Guideline 4000 5.0 Main Processing Unit Recalled for Electrical Defect

    FHC, Inc. is recalling six Guideline 4000 5.0 Main Processing Units because an electrical sub-circuit was not properly connected, potentially affecting performance during ESD events.

    Product
    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 Number: C0215 UDI: 00873263006740
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2358-2018·2018-07-11

    FHC Depth Stop Adapter Recall Due to Lead Damage Risk

    FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring surgical replacement.

    Product
    microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2359-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Lead Damage Risk

    FHC, Inc. is recalling Depth Stop Adapters because over-tightening the screw can damage implanted leads, requiring removal and replacement.

    Product
    microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2351-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead Damage

    FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage the implanted lead, requiring removal and replacement.

    Product
    microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2355-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead Damage

    FHC, Inc. is recalling the microTargeting Drive System Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring replacement.

    Product
    microTargeting" Drive System Distributed by Medtronic, Product Number FC1006
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2350-2018·2018-07-11

    FHC Depth Stop Adapter Recall Due to Lead and Stylet Damage

    FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads and stylets, requiring replacement.

    Product
    microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2352-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead Damage

    FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads, causing short circuits and requiring replacement.

    Product
    microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2345-2018·2018-07-11

    FHC microTargeting Drive System Recalled for Lead Damage Risk

    FHC, Inc. is recalling 2,952 microTargeting Drive Systems because over-tightening the depth stop screw can damage implanted leads, requiring replacement.

    Product
    microTargeting" Drive System, Product Number MT-DS
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2347-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead Damage

    FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter may damage implanted leads if over-tightened, potentially requiring replacement.

    Product
    microTargeting" Drive System, Product Number 66-ZD-MD
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2346-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Lead and Stylet Damage

    FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter can damage implanted leads and stylets when over-tightened, requiring device replacement.

    Product
    microTargeting" Drive System, Product Number MT-DS-01
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2354-2018·2018-07-11

    FHC Depth Stop Adapter Recall for Potential Lead Damage

    FHC, Inc. is recalling microTargeting Lead Adapters because over-tightening the depth stop screw can damage implanted leads, requiring replacement.

    Product
    microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2348-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Lead and Stylet Damage

    FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter can damage leads and stylets, potentially causing short circuits.

    Product
    microTargeting" Drive System, Product Number 66-ZD-MD-01
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2349-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead Damage

    FHC, Inc. is recalling the microTargeting STar Drive System (Manual) because the Depth Stop Adapter may damage the lead and stylet if the screw is over-tightened.

    Product
    microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2356-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead and Stylet Damage

    FHC, Inc. is recalling the microTargeting Drive System Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring replacement.

    Product
    microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2357-2018·2018-07-11

    FHC Depth Stop Adapter Recall for Lead Damage Risk

    FHC, Inc. is recalling the microTargeting STar Drive System (Manual) because the Depth Stop Adapter can damage implanted leads if over-tightened, requiring replacement.

    Product
    microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2353-2018·2018-07-11

    FHC Depth Stop Adapter Recall Due to Lead Damage Risk

    FHC, Inc. is recalling microTargeting Lead Adapters because over-tightening the depth stop screw can damage the lead and stylet, potentially requiring surgical replacement.

    Product
    microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB
    Category
    Medical Device
    Distribution
    46 states