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Kerecis® GraftGuide®
KERECIS hf. · Model 250 sq cm · UDI-DI 05694310960656
KGN
Prescription
10
510(k) clearances
185
Adverse events (1 deaths)
23
Recalls
138
Facilities
Description
Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide® is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-graftguide/
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-02-10 | Medline Industries, LP | Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic |
| 2023-05-23 | TEI Biosciences, Inc. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| 2023-05-23 | TEI Biosciences, Inc. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| 2023-05-23 | TEI Biosciences, Inc. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| 2023-05-23 | TEI Biosciences, Inc. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.