Food, drugs, devices › Amerx Health Care Corp.
Device recall: Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
FDA enforcement event 69083 is a device recall by Amerx Health Care Corp. of Clearwater, FL, initiated 11 Jul 2014 and classified Class II, with 4 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 22 Jul 2015. Initiation: voluntary: firm initiated. Amerx Health Care Corp. has 4 enforcement events on this register, with a median of 4 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Amerx Health Care Corp., Clearwater, FL.
Reason for recall
"Not approved labeling claims (antimicrobial and autolytic debridement)"
Distribution
"Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2638-2014 | Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management. | 382,620 units | Class II | Terminated | 24 Sep 2014 |
| Z-2639-2014 | Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management. | 21,108 units | Class II | Terminated | 24 Sep 2014 |
| Z-2640-2014 | Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management. | 116,633 units | Class II | Terminated | 24 Sep 2014 |
| Z-2641-2014 | Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management. | 1,740 units | Class II | Terminated | 24 Sep 2014 |
Context
Other enforcement events for Amerx Health Care Corp.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 May 2016 | Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. | Device | Class II | 1 |
| 25 Feb 2015 | Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management. | Device | Class II | 1 |
| 26 Sep 2014 | Amerigel Hydrogel Wound Dressing Wound management | Device | Class II | 4 |
All 4 events for Amerx Health Care Corp.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Not approved labeling claims (antimicrobial and autolytic debridement)"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Jul 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.