FDA Devices recall · Reported June 8, 2016
Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
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 durin…
Natus Medical Incorporated recalled Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue … - a moderate-severity action.
Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue … was recalled by Natus Medical Incorporated in June 8, 2016. Reason: The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly c…. Check the official notice for the remedy. Verify recall #Z-1878-2016 with the FDA Devices before acting.
The recall
Natus Medical Incorporated issued this moderate-severity FDA Devices recall-The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly c….
- Moderate
- severity level
- Class II
- classification
- June 8, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1878-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1878-2016 |
| Date reported | June 8, 2016 |
| Date initiated | April 22, 2016 |
| Recalling firm | Natus Medical Incorporated |
| Firm location | Seattle, WA |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1878-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026