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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69394

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

Open FDA event record

Event summary

Timeline bucket
September 26, 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 Hydrogel Wound Dressing Wound management

Z-0497-2015
Recall number
Z-0497-2015
Initiated
September 26, 2014
Classification
Class II
Status
Terminated
Recalling firm
Amerx Health Care Corp.
Quantity
340,896

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Formulation deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Formulation deviation

Code information

Model # A2001, Lot #s: YWD13, YWD15, YWD16, 2WD01, 2WD02, 2WD03, 2WD04, 2WD05, 2WD08, 2WD09, 2WD11, 2WD13, 2WD14, 2WD15, 2WD17, 2WD18, 3WD01, 3WD02, 3WD03, 3WD04, 3WD05

Distribution pattern

Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, 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, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.

device · product 2 of 4

Amerigel Post-op Surgical Kits Wound management

Z-0498-2015
Recall number
Z-0498-2015
Initiated
September 26, 2014
Classification
Class II
Status
Terminated
Recalling firm
Amerx Health Care Corp.
Quantity
79,677

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Formulation deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Formulation deviation

Code information

Model # A2002, Lot #s: JCA0086, JCA0087, JCA0088, JCA0089, JCA0090, JCA0091, JCA0092, JCA0093, JCA0094, JCA0095, JCA0096, JCA0097, JCA0098, JCA0099, JCA0100, JCA0101, JCA0102, JCA0103, JCA0104, JCA0105, JCA0106

Distribution pattern

Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, 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, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.

device · product 3 of 4

Amerigel Daily Dressing Packets Wound management

Z-0499-2015
Recall number
Z-0499-2015
Initiated
September 26, 2014
Classification
Class II
Status
Terminated
Recalling firm
Amerx Health Care Corp.
Quantity
1740

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Formulation deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Formulation deviation

Code information

Model # A2003, Lot #s: 2WD07

Distribution pattern

Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, 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, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.

device · product 4 of 4

Amerigel Saturated Gauze Dressing Wound management

Z-0500-2015
Recall number
Z-0500-2015
Initiated
September 26, 2014
Classification
Class II
Status
Terminated
Recalling firm
Amerx Health Care Corp.
Quantity
21,108

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Formulation deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Formulation deviation

Code information

Model # A5002, Lot #s: 05368, 05345, 09282, 10295, 12201, 12303, 12322, 12328, 13100, 13115, 13180

Distribution pattern

Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, 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, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.