CLASS II Device recall · Reported 8 Jun 2016 · FDA Enforcement Report

Replacement HEPA filter for Natus Sterile-Drier recalled

Natus Medical is recalling Replacement HEPA filter for Natus Sterile-Drier, distributed in 18 states. The recall was initiated on 22 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesFilter Serial Numbers: Filter SN: 2522893, 2522897, 2522898, 2522899, 2522900, 2522903, 2522914, 2522915, 2522916, 2522917, 2522918, 2522919, 2522920, 2522921, 2522922, 2522923, 2522924, 2522925, 2522926, 2522930, and 2522931.

Quantity recalled21 filters

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1878-2016
FDA event ID: 74004
Recalling firm: Natus Medical, Seattle, WA
Classification: Class II
Status: Terminated
Recall initiated: 22 Apr 2016
FDA classified: 1 Jun 2016
Reported: 8 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Other Medical Devices

Timeline

22 Apr 2016	Recall initiated by company
1 Jun 2016	Classified by FDA	+40 days
8 Jun 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

distributed in the US including AZ, CA, FL, IL, KS, MA, MD, MN, NC, NH, NY, OH, OK, PA, VA, WA, WA DC,and WI and in Canada and Singapore.

Arizona California District of Columbia Florida Illinois Kansas Massachusetts Maryland Minnesota North Carolina New Hampshire New York Ohio Oklahoma Pennsylvania Virginia Washington Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

Filter Serial Numbers: Filter SN: 2522893, 2522897, 2522898, 2522899, 2522900, 2522903, 2522914, 2522915, 2522916, 2522917, 2522918, 2522919, 2522920, 2522921, 2522922, 2522923, 2522924, 2522925, 2522926, 2522930, and 2522931.

Where was it sold?

distributed in the US including AZ, CA, FL, IL, KS, MA, MD, MN, NC, NH, NY, OH, OK, PA, VA, WA, WA DC,and WI and in Canada and Singapore.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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