Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 24, 2014
Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.
Not approved labeling claims (antimicrobial and autolytic debridement)
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Amerx Health Care Corp. recalled Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply … - a moderate-severity action.
Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply … was recalled by Amerx Health Care Corp. in September 24, 2014. Reason: Not approved labeling claims (antimicrobial and autolytic debridement). Check the official notice for the remedy. Verify recall #Z-2639-2014 with the FDA Devices before acting.
The recall
Amerx Health Care Corp. issued this moderate-severity FDA Devices recall-Not approved labeling claims (antimicrobial and autolytic debridement).
- Moderate
- severity level
- 21K units
- affected scope
- Class II
- classification
- September 24, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2639-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2639-2014) was formally reported on September 24, 2014, with the manufacturer initiating the action on July 11, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Amerx Health Care Corp. is listed as the recalling firm, operating out of Clearwater, FL. Federal records list the affected scope as 21,108 units.
The documented reason for this recall is: Not approved labeling claims (antimicrobial and autolytic debridement) Distribution data in the federal record shows the product reached: 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, MD, MI, MT, MO, NC, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
21,108 units
Related Recalls
6
3 from same agency
Product description
Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.
Reason for recall
Not approved labeling claims (antimicrobial and autolytic debridement)
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2639-2014 |
| Date reported | September 24, 2014 |
| Date initiated | July 11, 2014 |
| Recalling firm | Amerx Health Care Corp. |
| Firm location | Clearwater, FL |
| Affected scope | 21,108 units |
| 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, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2639-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.. Recalled by Amerx Health Care Corp.. Units affected: 21,108 units.
Why was this product recalled? ▼
Not approved labeling claims (antimicrobial and autolytic debridement)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 24, 2014. Severity: Moderate. Recall number: Z-2639-2014.
Where was the recalled product distributed? ▼
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, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and WV, and the countries of Canada, England, Africa, and Australia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2639-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 24, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.