CAPNOSTREAM 20P (INTL) N - ROHS
Medical device recall Z-0038-2019. Published in FDA’s Enforcement Report on Oct 10, 2018.
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 Oct 10, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 474 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?
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-02
474, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
B836141168 B836141196 B836141198 B836141206 B836141207 B836141209 B836141210 B836141212 B836141214 B836141217 B836141218 B836141221 B836141222 B836141223 B836141225 B836141226 B836141229 B836141230 B837141231 B837141232 B839141793…
Every code shown here, 1,991 characters
B836141168 B836141196 B836141198 B836141206 B836141207 B836141209 B836141210 B836141212 B836141214 B836141217 B836141218 B836141221 B836141222 B836141223 B836141225 B836141226 B836141229 B836141230 B837141231 B837141232 B839141793 B840141875 B839141678 B839141682 B839141712 B841142027 B841142029 B841142033 B843142241 B844142389 B844142406 B844142411 B844142423 B844142426 B844142443 B844142449 B847142891 B847142906 B847142923 B847142938 B847142945 B847142947 B848142952 B848142970 B848142994 B848143001 B848143002 B801153800 B803153963 B803153964 B803153965 B803153968 B803153970 B803153971 B803153974 B803153975 B803153979 B803153981 B803153982 B803153983 B803153984 B803153985 B803153990 B841142053 B841142067 B851143673 B852143682 B850143423 B850143424 B850143425 B850143449 B850143450 B852143708 B852143715 B852143719 B852143736 B852143738 B852143743 B852143747 B852143750 B852143751 B852143755 B852143756 B852143757 B852143758 B852143760 B852143761 B852143762 B852143763 B852143766 B852143767 B852143768 B852143770 B852143772 B852143773 B852143776 B852143777 B852143778 B852143780 B852143782 B852143783 B852143785 B852143786 B852143787 B852143788 B852143792 B852143793 B852143794 B808154912 B808154964 B808155000 B809155003 B810155087 B810155099 B810155108 B810155117 B810155120 B810155144 B812155509 B812155546 B812155549 B812155551 B812155556 B812155559 B812155560 B812155566 B812155569 B812155586 B812155587 B812155592 B812155607 B812155609 B812155610 B809155067 B810155097 B810155195 B810155245 B810155246 B810155256 B810155261 B810155263 B810155264 B816156024 B816156043 B816156045 B816156047 B816156049 B816156051 B816156052 B816156061 B816156063 B816156064 B816156065 B816156069 B816156072 B816156075 B816156083 B803153993 B803154001 B803154036 B806154401 B806154424 B806154455 B807154583 B807154653 B807154718 B807154790 B808154968 B808154981 B809155031 B809155056 B810155076 B810155110 B810155125 B810155143 B810155171 B810155202 B810155220 B810155226 B810155228 B810155241…
FDA’s list runs to 5,213 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.
The products were distributed US nationwide and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Mexico, Netherlands, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, UAE, UK, and Vietnam.
The states and territories these words name
- Puerto Rico
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 Jul 31, 2018.
- FDA classified it on Oct 3, 2018.
- FDA’s Enforcement Report published it on Oct 10, 2018.
- FDA terminated it on Sep 20, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Oridion Medical 1987 Ltd., of Jerusalem, Israel.
- 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 5,213 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
-
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.