Class II — Potential Health Hazard

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

External Drainage System Collection Bag Recalled by Natus Medical Incorporated Due to Sterility assurance cannot be guaranteed for external drainage...

Date: November 28, 2023
Company: Natus Medical Incorporated
Status: Ongoing
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 Natus Medical Incorporated directly.

Affected Products

External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only

Quantity: 2,686 units

Why Was This Recalled?

Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Natus Medical Incorporated

Natus Medical Incorporated has 18 total recalls tracked by RecallDetector.

Related Recalls

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