Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69083

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 11, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Amerx Health Care Corp.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.

Z-2638-2014
Recall number
Z-2638-2014
Initiated
July 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Amerx Health Care Corp.
Quantity
382,620 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Not approved labeling claims (antimicrobial and autolytic debridement)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Not approved labeling claims (antimicrobial and autolytic debridement)

Code information

Lot codes: 3WD02, 3WD03, 3WD04, and 3WD05

Distribution pattern

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.

device · product 2 of 4

Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.

Z-2639-2014
Recall number
Z-2639-2014
Initiated
July 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Amerx Health Care Corp.
Quantity
21,108 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Not approved labeling claims (antimicrobial and autolytic debridement)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Not approved labeling claims (antimicrobial and autolytic debridement)

Code information

Lot codes: 05368, 05345, 09282, 10295, 12201, 12303, 12303, 12328, 13100, 13115, and 13180.

Distribution pattern

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.

device · product 3 of 4

Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.

Z-2640-2014
Recall number
Z-2640-2014
Initiated
July 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Amerx Health Care Corp.
Quantity
116,633 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Not approved labeling claims (antimicrobial and autolytic debridement)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Not approved labeling claims (antimicrobial and autolytic debridement)

Code information

Lot codes: JCA0086 through JCA0106.

Distribution pattern

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.

device · product 4 of 4

Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.

Z-2641-2014
Recall number
Z-2641-2014
Initiated
July 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Amerx Health Care Corp.
Quantity
1,740 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Not approved labeling claims (antimicrobial and autolytic debridement)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Not approved labeling claims (antimicrobial and autolytic debridement)

Code information

Lot codes: 2WD07.

Distribution pattern

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.