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KGNClass U

Wound Dressing With Animal-Derived Material(S)

FDA adverse event reports and recall history for wound dressing with animal-derived material(s) (product code KGN), from the public MAUDE/AEMS corpus and the live FDA recall database.

Total reports
185
Deaths
1
Injuries
139
Malfunctions
31

Reports per year

12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

  • 2026-04-15Open, ClassifiedUnder Investigation by firm

    Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.

    Increased rate of out-of-specification endotoxin results.

  • 2026-04-15Open, ClassifiedUnder Investigation by firm

    Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.

    Increased rate of out-of-specification endotoxin results.

  • 2026-04-15Open, ClassifiedUnder Investigation by firm

    Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.

    Increased rate of out-of-specification endotoxin results.

  • 2026-04-15Open, ClassifiedUnder Investigation by firm

    Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.

    Increased rate of out-of-specification endotoxin results.

  • 2026-04-15Open, ClassifiedUnder Investigation by firm

    Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.

    Increased rate of out-of-specification endotoxin results.

  • 2026-03-27Open, ClassifiedUnder Investigation by firm

    Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"

    Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.

  • 2024-09-30Open, ClassifiedUnder Investigation by firm

    PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.

    Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

  • 2024-09-30Open, ClassifiedUnder Investigation by firm

    PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).

    Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

  • 2024-09-30Open, ClassifiedUnder Investigation by firm

    PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).

    Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

  • 2024-09-30Open, ClassifiedUnder Investigation by firm

    PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.

    Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

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