Naera Hospital Bassinet
Medical device recall Z-0813-2019. Published in FDA’s Enforcement Report on Feb 13, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 13, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 5915 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Naera Hospital Bassinet, Model No. 4402
5915, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
2016000600003 2016000600004 2016000600005 2016000600006 2016000600007 2016000600008 2016000600009 2016000600010 2016000600011 2016000600012 2016000600013 2016000600014 2016000600015 2016000600016 2016000600017 2016000600018 2016000600019…
Every code shown here, 1,988 characters
2016000600003 2016000600004 2016000600005 2016000600006 2016000600007 2016000600008 2016000600009 2016000600010 2016000600011 2016000600012 2016000600013 2016000600014 2016000600015 2016000600016 2016000600017 2016000600018 2016000600019 2016000600020 2016000600021 2016000600022 2016000600023 2016000600024 2016000600025 2016000600026 2016000600027 2016000600028 2016000600029 2016000600030 2016000600031 2016000600032 2016000600033 2016000600034 2016000600035 2016000600036 2016000600037 2016000600038 2016000600039 2016000600040 2016000600041 2016000600042 2016000600043 2016000600044 2016000600045 2016000600046 2016000600047 2016000600048 2016000600049 2016000600050 2016000600054 2016000600059 2016000600060 2016000600061 2016000600062 2016000600063 2016000600064 2016000600065 2016000600066 2016000600067 2016000600068 2016000600069 2016000600070 2016000600073 2016000600082 2016000600083 2016000600084 2016000600085 2016000600086 2016000600087 2016000600088 2016000600089 2016000600090 2016000600091 2016000600092 2016000600093 2016000600094 2016000600095 2016000600096 2016000600097 2016000600098 2016000600099 2016000600100 2016000600101 2016000600102 2016000600103 2016000600104 2016000600105 2016000600106 2016000600107 2016000600108 2016000600109 2016000600110 2016000600111 2016000600112 2016000600113 2016000600114 2016000600115 2016000600116 2016000600117 2016000600118 2016000600119 2016000600120 2016000600121 2016000600122 2016000600123 2016000600124 2016000600125 2016000600126 2016000600127 2016000600128 2016000600129 2016000600130 2016000600131 2016000600132 2016000600133 2016000600134 2016000600135 2016000600136 2016000600137 2016000600138 2016000600139 2016000600140 2016000600141 2016000600142 2016000600143 2016000600144 2016000600145 2016000600146 2016000600147 2016000600148 2016000600149 2016000600150 2016000600151 2016000600152 2016000600153 2016000600154 2016000600155 2016000600156 2016000600157 2016000600158 2016000600159 2016000600160 2016000600161…
FDA’s list runs to 82,852 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide distribution. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Germany, India, Japan, Netherlands, South Africa, Turkey, Saudi Arabia, United Kingdom, and Mexico.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 10, 2018.
- FDA classified it on Feb 7, 2019.
- FDA’s Enforcement Report published it on Feb 13, 2019.
- FDA terminated it on Apr 29, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Medical Division of Stryker Corporation, of Portage, MI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 82,852 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.