CLASS II Device recall · Reported 24 Jun 2015 · FDA Enforcement Report
Amerigel Hydrogel Gauze Dressing , A5002 recalled by Amerx Health Care
Amerx Health Care is recalling Amerigel Hydrogel Gauze Dressing , A5002, distributed in 45 states. The recall was initiated on 25 Feb 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1797-2015
- FDA event ID
- 71161
- Recalling firm
- Amerx Health Care, Clearwater, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Feb 2015
- FDA classified
- 12 Jun 2015
- Reported
- 24 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 25 Feb 2015 | Recall initiated by company | |
| 12 Jun 2015 | Classified by FDA | +107 days |
| 24 Jun 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Nonapproved labeling claims (Sterile)
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
Where it was distributed
Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Why was it recalled?
Nonapproved labeling claims (Sterile)
Which lots are affected?
ALL Lots - 11406, 11414, 12439, 12466, and 02521.
Where was it sold?
Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Amerx Health Care
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Amerigel Hydrogel Wound Dressing Advanced Formula recalled | Amerx Health Care | Potency & Assay | 26 states |
| Device | CLASS II | Amerigel Daily Dressing Packets Wound management recalled | Amerx Health Care | Processing Deviation | Nationwide |
| Device | CLASS II | Amerigel Hydrogel Wound Dressing Wound management recalled | Amerx Health Care | Processing Deviation | Nationwide |
| Device | CLASS II | Amerigel Post-op Surgical Kits Wound management recalled | Amerx Health Care | Processing Deviation | Nationwide |
| Device | CLASS II | Amerigel Saturated Gauze Dressing Wound management recalled | Amerx Health Care | Processing Deviation | Nationwide |
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