# FDA recall Z-0813-2019

> **Stryker Medical Division of Stryker Corporation** · Class II · device recall initiated 2018-10-10.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-0813-2019
- **Recalling firm:** Stryker Medical Division of Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-10
- **Report date:** 2019-02-13
- **Termination date:** 2020-04-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portage, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0813-2019

## Citation

> AI Analytics. FDA recall Z-0813-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0813-2019. Source: US FDA. Licensed CC0.

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