Naera Hospital Bassinet — Class II medical device recall Z-0813-2019
Terminated recall by Stryker Medical Division of Stryker Corporation, reported 2019-02-13, distributed nationwide. It was identified that the volume of air inside the mattress may expand in regions of high altitude which may
| Recall number | Z-0813-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Medical Division of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2018-10-10 |
| Classified | 2019-02-07 |
| Reported by FDA | 2019-02-13 |
| Terminated | 2020-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, CL, CN, CO, DE, GB, IN, JP, MX, NL, SA, TR, ZA |
| Quantity | 5,915 |
| UPC / GTIN / UDI-DI | 02016000600018, 02016000600025, 02016000600032, 02016000600049, 02016000600063, 02016000600070, 02016000600087, 02016000600094, 02016000600100, 02016000600117, 02016000600124, 02016000600131, 02016000600148, 02016000600155, 02016000600162, 02016000600179, 02016000600186, 02016000600193, 02016000600209, 02016000600230, 02016000600247, 02016000600254, 02016000600261, 02016000600278, 02016000600285 and 475 more |
| Model numbers | 4402 |
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.
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-0813-2019. 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.