Capnostream20 (US) M W/PRINTER
Medical device recall Z-0029-2019. 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
- 500 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?
Capnostream20 (US) M W/PRINTER, Part Number CS08659
500, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
B300001010 B300001017 B300001011 B300001056 B300001135 B300001270 B300001318 B300001326 B300001439 B300001396 B300001422 B300001323 B300001327 B300001328 B300001332 B300001264 B500001508 B500001470 B500001471 B500001509 B500001524…
Every code shown here, 1,991 characters
B300001010 B300001017 B300001011 B300001056 B300001135 B300001270 B300001318 B300001326 B300001439 B300001396 B300001422 B300001323 B300001327 B300001328 B300001332 B300001264 B500001508 B500001470 B500001471 B500001509 B500001524 B300001404 B300001398 B300001377 B300001386 B300001107 B300001212 B300001308 B300001314 B300001016 B300001128 B300001235 B300001285 B300001291 B300001258 B500001647 B500001731 B500001711 B500001723 B500001735 B300001412 B500001717 B500001732 B300001137 B300001146 B300001147 B300001352 B300001393 B300001408 B500001517 B300001302 B500001827 B500001830 B500001832 B500001839 B500001845 B500001856 B500001858 B500001859 B500001860 B500001861 B500001864 B500001866 B500001868 B500001869 B500001871 B500001875 B500001876 B500001879 B500001881 B500001882 B500001884 B500001886 B500001887 B500001888 B500001889 B500001891 B500001895 B500001896 B500001904 B500001906 B500001907 B500001908 B500001910 B500001911 B500001924 B500001930 B500001932 B500001933 B500001934 B500001935 B500001939 B500001944 B500001954 B500001957 B500001958 B500001961 B500001963 B500001965 B500001967 B500001968 B500001970 B500001971 B500001973 B500001974 B500001978 B500001981 B500001983 B500001986 B500001987 B500001988 B500001990 B500001991 B500001992 B500001994 B500001995 B500001996 B500001997 B500001998 B500001999 B500002000 B500002001 B500002002 B500002003 B500002004 B500002005 B500002006 B500002007 B500002008 B500002010 B500002012 B500002015 B300001363 B500001857 B500001863 B500001877 B500001880 B500001834 B500001848 B300001036 B300001117 B300001138 B300001271 B300001104 B300001158 B300001202 B300001281 B300001321 B300001330 B300001331 B300001354 B300001375 B300001392 B300001082 B300001142 B300001169 B300001200 B300001224 B500001472 B500001473 B500001474 B300001402 B500001556 B500001842 B500001865 B500001878 B500001899 B500001916 B500001952 B500001475 B500001512 B500002092 B500002105 B500002147 B500001966 B500002060 B500002072 B500002074 B500002088 B500002099 B500002106…
FDA’s list runs to 5,499 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 5,499 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.