Naera Hospital Bassinet
Stryker is a global leader in medical technology, providing innovative solutions for healthcare professionals and patients worldwide.
Lower-risk 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.
Contact the company
What happened, in plain English
Stryker is a global leader in medical technology, providing innovative solutions for healthcare professionals and patients worldwide. Read more at govinfonow.com/recall/69651-stryker.
Source Summary by GovInfoNow · govinfonow.com/recall/69651-stryker · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0813-2019
Cite this page
“Naera Hospital Bassinet.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/69651-stryker. Based on FDA recall #Z-0813-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0813-2019%22&limit=1).
Why it’s dangerous
Stryker is a reputable medical device manufacturer with a long history of providing safe and effective products. The company is not associated with any known security vulnerabilities or malicious activities.
Who’s affected
All healthcare professionals and patients
How to tell if you have this one
Ensure that you are using the latest version of Stryker products and that they are properly maintained and updated.
- Brand
Stryker- Category
Medical device
What to do — step by step
1
Verify that you are using the latest version of Stryker products.
2
Ensure that all Stryker products are properly maintained and updated.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0813-2019 (October 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0813-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.