Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 13, 2019
Naera Hospital Bassinet, Model No. 4402
It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patie…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Stryker Medical Division of Stryker Corporation recalled Naera Hospital Bassinet, Model No. 4402 - a moderate-severity action.
Naera Hospital Bassinet, Model No. 4402 was recalled by Stryker Medical Division of Stryker Corporation in February 13, 2019. Reason: It was identified that the volume of air inside the mattress may expand in regions of high altitude which may…. Check the official notice for the remedy. Verify recall #Z-0813-2019 with the FDA Devices before acting.
The recall
Stryker Medical Division of Stryker Corporation issued this moderate-severity FDA Devices recall-It was identified that the volume of air inside the mattress may expand in regions of high altitude which may….
- Moderate
- severity level
- 6K units
- affected scope
- Class II
- classification
- February 13, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0813-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0813-2019) was formally reported on February 13, 2019, with the manufacturer initiating the action on October 10, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Medical Division of Stryker Corporation is listed as the recalling firm, operating out of Portage, MI. Federal records list the affected scope as 5915.
The documented reason for this recall is: It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface and tub. A Health Hazard Eval… Distribution data in the federal record shows the product reached: Nationwide distribution. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Germany, India, Japan, Netherlands, South Africa, Turkey, Saudi Arabia, United Kingdom, and Mexico.. Distribution scope 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 - 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 - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
5915
Related Recalls
6
0 from same agency
Product description
Naera Hospital Bassinet, Model No. 4402
Reason for recall
It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface and tub. A Health Hazard Evaluation was completed which identified the potential risk of patients moving out of position and rolling over on the mattress. While the highest possible severity of harm associated with this condition is death, there have been no reports of injury or harm. This condition has only presented in regions of high altitude; however, Stryker has chosen to replace all Naera mattresses in the field.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0813-2019 |
| Date reported | February 13, 2019 |
| Date initiated | October 10, 2018 |
| Recalling firm | Stryker Medical Division of Stryker Corporation |
| Firm location | Portage, MI |
| Affected scope | 5915 |
| Distribution | Nationwide distribution. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Germany, India, Japan, Netherlands, South Africa, Turkey, Saudi Arabia, United Kingdom, and Mexico. |
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-0813-2019) 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.
Frequently Asked Questions
What product was recalled? ▼
Naera Hospital Bassinet, Model No. 4402. Recalled by Stryker Medical Division of Stryker Corporation. Units affected: 5915.
Why was this product recalled? ▼
It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface and tub. A Health Hazard Evaluation was completed which identified the potential risk of patients moving out of position and rolling over on the mattress. While the highest possible severity of harm associated with this condition is death, there have been no reports of injury or harm. This condition has only presented in regions of high altitude; however, Stryker has chosen to replace all Naera mattresses in the field.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 13, 2019. Severity: Moderate. Recall number: Z-0813-2019.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Germany, India, Japan, Netherlands, South Africa, Turkey, Saudi Arabia, United Kingdom, and Mexico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0813-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 13, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.