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CellerateRX

APPLIED NUTRITIONALS, LLC · Model CRXG-28GMEA · UDI-DI 00850019972092

KGN Prescription

510(k) clearances

185

Adverse events (1 deaths)

Recalls

136

Facilities

Description

CellerateRX is Type I bovine hydrolyzed collagen gel for chronic and acute wounds including partial and full-thickness wounds, pressure injuries 1-4, venous stasis ulcers, arterial ulcers, diabetic ulcers, surgical wounds, traumatic wounds, first and second-degree burns, and superficial wounds. Sterile until opened. Store at room temperature. For use in management of lightly to moderately exudative wounds. Cleanse the wound per facility protocol. Apply CellerateRX over the entire wound bed and the edges of the wound. Cover with an appropriate dressing. Reapply CellerateRX a minimum of 2-3 times per week, or with each dressing change, taking care not to disrupt the wound site. www.sanaramedtech.com.

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.