Class II — Potential Health Hazard

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

Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model Recalled by Natus Medical Incorporated Due to The replacement HEPA Filters have been manufactured with...

Date: April 22, 2016
Company: Natus Medical Incorporated
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 Natus Medical Incorporated directly.

Affected Products

Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.

Quantity: 21 filters

Why Was This Recalled?

The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during use, contaminating the interior chamber of the Sterile Drier and its contents.

Where Was This Sold?

This product was distributed to 18 states: AZ, CA, FL, IL, KS, MD, MA, MN, NH, NY, NC, OH, OK, PA, VA, WA, WI, DC

Affected (18 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