Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44 — Class II medical device recall Z-1878-2016
Terminated recall by Natus Medical Incorporated, reported 2016-06-08, distributed in AZ, CA, DC, FL, IL, KS, MA, MD…. The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cu
| Recall number | Z-1878-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Medical Incorporated, Seattle, WA, United States |
| Recall initiated | 2016-04-22 |
| Classified | 2016-06-01 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2016-12-16 |
| Distributed | AZ, CA, DC, FL, IL, KS, MA, MD, MN, NC, NH, NY, OH, OK, PA, VA, WA, WI |
| Countries outside the US | CA, SG |
| Quantity | 21 filters |
| Reason classes | sterility |
| Model numbers | 100105-01, 54343, 54344 |
Product
Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1878-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.