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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85034

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

Open FDA event record

Event summary

Timeline bucket
February 27, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Gentell, Inc

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

Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

Z-1623-2020
Recall number
Z-1623-2020
Initiated
February 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Gentell, Inc
Quantity
53,134

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an FDA audit, it was discovered that the product was not properly registered with FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During an FDA audit, it was discovered that the product was not properly registered with FDA.

Code information

1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1118819 1121419 1124919

Distribution pattern

Worldwide distribution  US Nationwide distribution in the states of AL, CA, FL, IA, IL, KY, MA, MI, MN, NC, NJ, NY, OH, OK, PA, Puerto Rico, RI, SC, TN, TX, WI and countries of Panama, South Africa, Bahrain, Spain, Mexico, Costa Rica, Romania.

device · product 2 of 4

Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

Z-1624-2020
Recall number
Z-1624-2020
Initiated
February 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Gentell, Inc
Quantity
20,025

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an FDA audit, it was discovered that the product was not properly registered with FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During an FDA audit, it was discovered that the product was not properly registered with FDA.

Code information

1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1118819 1121419 1124919

Distribution pattern

Worldwide distribution  US Nationwide distribution in the states of AL, CA, FL, IA, IL, KY, MA, MI, MN, NC, NJ, NY, OH, OK, PA, Puerto Rico, RI, SC, TN, TX, WI and countries of Panama, South Africa, Bahrain, Spain, Mexico, Costa Rica, Romania.

device · product 3 of 4

Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

Z-1625-2020
Recall number
Z-1625-2020
Initiated
February 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Gentell, Inc
Quantity
6,433

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an FDA audit, it was discovered that the product was not properly registered with FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During an FDA audit, it was discovered that the product was not properly registered with FDA.

Code information

1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1118819 1121419 1124919

Distribution pattern

Worldwide distribution  US Nationwide distribution in the states of AL, CA, FL, IA, IL, KY, MA, MI, MN, NC, NJ, NY, OH, OK, PA, Puerto Rico, RI, SC, TN, TX, WI and countries of Panama, South Africa, Bahrain, Spain, Mexico, Costa Rica, Romania.

device · product 4 of 4

Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

Z-1626-2020
Recall number
Z-1626-2020
Initiated
February 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Gentell, Inc
Quantity
6,395

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an FDA audit, it was discovered that the product was not properly registered with FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During an FDA audit, it was discovered that the product was not properly registered with FDA.

Code information

1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1121419 1124919

Distribution pattern

Worldwide distribution  US Nationwide distribution in the states of AL, CA, FL, IA, IL, KY, MA, MI, MN, NC, NJ, NY, OH, OK, PA, Puerto Rico, RI, SC, TN, TX, WI and countries of Panama, South Africa, Bahrain, Spain, Mexico, Costa Rica, Romania.