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Amerx Health Care Corp.

Complete recall history across all FDA and CPSC categories — 10 total recalls

Amerx Health Care Corp. 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 (10)

FDA medical device enforcement actions by Amerx Health Care Corp.

Date Product Reason Class
May 20, 2016 Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. Product did not meet specifications for Zinc Acetate (OOS). Class II
Feb 25, 2015 Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management. Nonapproved labeling claims (Sterile) Class II
Sep 26, 2014 Amerigel Daily Dressing Packets Wound management Formulation deviation Class II
Sep 26, 2014 Amerigel Hydrogel Wound Dressing Wound management Formulation deviation Class II
Sep 26, 2014 Amerigel Post-op Surgical Kits Wound management Formulation deviation Class II
Sep 26, 2014 Amerigel Saturated Gauze Dressing Wound management Formulation deviation Class II
Jul 11, 2014 Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amer... Not approved labeling claims (antimicrobial and autolytic debridement) Class II
Jul 11, 2014 Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management. Not approved labeling claims (antimicrobial and autolytic debridement) Class II
Jul 11, 2014 Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets... Not approved labeling claims (antimicrobial and autolytic debridement) Class II
Jul 11, 2014 Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads siz... Not approved labeling claims (antimicrobial and autolytic debridement) 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.

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