Z-1878-2016Class II

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

Name: Z-1878-2016 Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343...
Creator: Natus Medical Incorporated
Published: 2016-04-22
License: https://open.fda.gov/license/

Natus Medical Incorporated / initiated 2016-04-22 / Terminated / root cause: manufacturing process

FDA source

Natus Medical Incorporated began a recall of Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01 on 2016-04-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1878-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-22
Posted: 2016-06-01
Terminated: 2016-12-16
Recalling firm: Natus Medical Incorporated
Product: Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
Product code: LDS Device, Pasteurization, Hot Water
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Natus sent an " URGENT RECALL NOTIFICATION/ FIELD SAFETY NOTICE" Olympic Sterile Driers Model 43 & 44, Replacement HEPA Filter Contamination letter (dated April 22, 2016) was sent to all affected customers on May 2, 2016. for the first set of customers and then sent on May 12, 2016, for the second set of customers, who purchased 57 replacement filters. Customers are advised "do not install any replacement HEPA filter" if the serial number is one of the 21 shown as affected serial numbers on the letter. The URGENT RECALL NOTIFICATION/ FIELD SAFETY NOTICE Olympic Sterile Driers Model 43 & 44, Potential HEPA Filter Contamination (dated May, 2016 and released on May 12, 2016,) was sent to customers on May 16, 2016, who purchased 11 sterile driers with the installed filters. Customers are advised "do not use the Sterile drier" if it contains a HEPA filter that is identified with one of 21 affected serial numbers. Customers are advised not to install any defective replacement HEPA filters or do not use sterile drier if it currently contains defective HEPA filter. Please discontinue use of the Sterile Drier immediately if it contains defective HEPA filter as heat may cause the uncured adhesive to drip into the chamber. Customers contact Natus to obtain the RMA number and return unused filters and Natus will provide a replacement filter. Please contact Natus at [email protected] or call 866-940-7143 (option 1, Olympic products) for next steps regarding a contaminated Sterile Drier.
Quantity in commerce: 21 filters
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1878-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1878-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-01

Product code LDS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)