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NuForra Surgical Wound Care

KAIROS BIOSCIENCES LLC · Model NUF-300 · UDI-DI 00860014518300

KGN Prescription

510(k) clearances

185

Adverse events (1 deaths)

Recalls

138

Facilities

Description

NuForra Surgical Wound Care consists of fibrous, Type I bovine collagen intended for the management of surgical wounds and a wide range of acute and chronic wounds. NuForra is designed to support a moist wound environment to promote natural healing. Indications for Use: Indicated for surgical wounds, partial- and full-thickness wounds, pressure ulcers (Stages I-IV), venous ulcers, ulcers caused by mixed vascular etiologies, venous stasis ulcers, diabetic ulcers, first- and second-degree burns, cuts, and abrasions. NuForra is suitable for application to surgical incision sites and wounds.

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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Data 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.