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NuMed Industries LLC.

Numed Industries, LLC · Model NM5050COL · UDI-DI 00819123010571

KGN Prescription

510(k) clearances

185

Adverse events (1 deaths)

Recalls

138

Facilities

Description

Type I Collagen is the most abundant type of collagen in the human body. As the main component of connective tissue, it is the most abundant protein in mammals, making up from 25% to 35% of the whole-body protein content. Collagen, in the form of elongated fibrils, is mostly found in fibrous tissues such as tendons, bones, ligaments and skin. The fibroblast is the most common cell which creates collagen. During wound healing, collagen encourages the deposition and organization of newly formed collagen fibers and granulation tissue in the wound bed. It also stimulates new tissue development and wound debridement, creating an environment conducive to healing. NuMed Collagen Dressings are made of a porous type 1, 100% bovine collagen membrane. They consist of a fibrous collagen network similar to the dermis, creating an environment conducive to healing.

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.