Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Reinforced Dual Lumen Cannula Recalled by OriGen Biomedical, Inc. Due to The catheter failed the endotoxin testing.

Date: August 21, 2018
Company: OriGen Biomedical, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact OriGen Biomedical, Inc. directly.

Affected Products

Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO

Quantity: 106

Why Was This Recalled?

The catheter failed the endotoxin testing.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About OriGen Biomedical, Inc.

OriGen Biomedical, Inc. has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report