Device recall: Amerigel Wound Dressing 1 oz. tube
FDA enforcement event 68488 is a device recall by Kova Laboratories, Inc. of Margate, FL, initiated 21 Mar 2014 and classified Class II, with 2 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 12 Sep 2016. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Kova Laboratories, Inc..
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Kova Laboratories, Inc., Margate, FL.
Reason for recall
"Product may not have been manufactured pursuant to a validated process protocol and CGMP."
Distribution
"Distributed in the states of FL and NJ."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1992-2014 | Amerigel Wound Dressing 1 oz. tube | 122,396 / 1oz. tubes | Class II | Terminated | 16 Jul 2014 |
| Z-1993-2014 | Amerigel Wound Dressing 55 gallons/drum | 3 drums | Class II | Terminated | 16 Jul 2014 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Product may not have been manufactured pursuant to a validated process protocol and CGMP."
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: "Distributed in the states of FL and NJ."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 Sep 2016. "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.