FHC, Inc.

Complete recall history across all FDA and CPSC categories — 17 total recalls

FHC, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (17)

FDA medical device enforcement actions by FHC, Inc.

Date Product Reason Class
Oct 4, 2024 microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended us... A complaint was received (MDR 3002250546-2024-00003) prompting an investigati... Class I
Jun 17, 2020 FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to... An electrical sub-circuit was not properly connected. Its purpose is to elimi... Class II
May 10, 2018 microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME The FHC Depth Stop Adapter may cause damage to the lead and stylet when the d... Class II
May 10, 2018 microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME The FHC Depth Stop Adapter may cause damage to the lead and stylet when the d... Class II
May 10, 2018 microTargeting" Drive System Distributed by Medtronic, Product Number FC1006 The FHC Depth Stop Adapter may cause damage to the lead and stylet when the d... Class II
May 10, 2018 microTargeting" Drive System, Product Number 66-ZD-MD-01 The FHC Depth Stop Adapter may cause damage to the lead and stylet when the d... Class II
May 10, 2018 microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB The FHC Depth Stop Adapter may cause damage to the lead and stylet when the d... Class II
May 10, 2018 microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product... The FHC Depth Stop Adapter may cause damage to the lead and stylet when the d... Class II
May 10, 2018 microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601 The FHC Depth Stop Adapter may cause damage to the lead and stylet when the d... Class II
May 10, 2018 microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB The FHC Depth Stop Adapter may cause damage to the lead and stylet when the d... Class II
May 10, 2018 microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Prod... The FHC Depth Stop Adapter may cause damage to the lead and stylet when the d... Class II
May 10, 2018 microTargeting" Drive System, Product Number MT-DS-01 The FHC Depth Stop Adapter may cause damage to the lead and stylet when the d... Class II
May 10, 2018 microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-A... The FHC Depth Stop Adapter may cause damage to the lead and stylet when the d... Class II
May 10, 2018 microTargeting" Drive System, Product Number 66-ZD-MD The FHC Depth Stop Adapter may cause damage to the lead and stylet when the d... Class II
May 10, 2018 microTargeting" Drive System, Product Number MT-DS The FHC Depth Stop Adapter may cause damage to the lead and stylet when the d... Class II
May 10, 2018 microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA The FHC Depth Stop Adapter may cause damage to the lead and stylet when the d... Class II
May 10, 2018 microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA The FHC Depth Stop Adapter may cause damage to the lead and stylet when the d... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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