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Gentell, Inc

Complete recall history across all FDA and CPSC categories — 11 total recalls

Recall Summary

3 Drug Recalls 8 Device Recalls

Gentell, Inc appears in recall records across 2 categories. 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.

Drug Recalls (3)

FDA drug safety enforcement actions by Gentell, Inc

Date Product Reason Class
Apr 19, 2017 Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz... GMP Deviations; product may not meet cGMP requirements Class II
Dec 15, 2016 Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-... CGMP Deviations Class II
Dec 15, 2016 Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell... CGMP Deviations Class II

Device Recalls (8)

FDA medical device enforcement actions by Gentell, Inc

Date Product Reason Class
Mar 26, 2020 Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing cont... During an FDA audit, it was discovered that the product was not properly regi... Class II
Mar 26, 2020 Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydroge... During an FDA audit, it was discovered that the product was not properly regi... Class II
Mar 26, 2020 Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing cont... During an FDA audit, it was discovered that the product was not properly regi... Class II
Mar 26, 2020 Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing cont... During an FDA audit, it was discovered that the product was not properly regi... Class II
Feb 27, 2020 Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care ... During an FDA audit, it was discovered that the product was not properly regi... Class II
Feb 27, 2020 Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care o... During an FDA audit, it was discovered that the product was not properly regi... Class II
Feb 27, 2020 Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a... During an FDA audit, it was discovered that the product was not properly regi... Class II
Feb 27, 2020 Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care ... During an FDA audit, it was discovered that the product was not properly regi... 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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