CAPNOSTREAM 20P (US) N W/PRINTER
Medical device recall Z-0026-2019. 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
- 1038 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 (US) N W/PRINTER, Part Number CS08657-01
1038, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
B400002777 B400002778 B400002779 B400002780 B400002781 B400002782 B400002783 B400002784 B400002785 B400002786 B600002902 B600002903 B600002905 B600002906 B600002908 B600002901 B600002904 B600002907 B632123517 B633123526 B621135542…
Every code shown here, 1,991 characters
B400002777 B400002778 B400002779 B400002780 B400002781 B400002782 B400002783 B400002784 B400002785 B400002786 B600002902 B600002903 B600002905 B600002906 B600002908 B600002901 B600002904 B600002907 B632123517 B633123526 B621135542 B621135543 B621135544 B621135545 B621135546 B621135547 B621135548 B621135549 B621135550 B621135551 B621135552 B621135553 B621135554 B621135555 B621135556 B621135557 B621135558 B621135559 B621135560 B621135561 B621135562 B621135564 B621135566 B621135568 B621135569 B621135570 B621135571 B621135572 B621135573 B621135574 B621135575 B621135577 B621135578 B621135580 B621135582 B621135583 B621135584 B621135585 B621135586 B621135587 B621135589 B621135590 B621135591 B621135592 B621135594 B621135595 B621135588 B621135593 B633137055 B633137058 B633137060 B633137061 B633137062 B633137063 B633137064 B633137065 B633137066 B633137068 B633137069 B634137070 B634137071 B634137072 B634137073 B634137074 B634137075 B634137076 B634137077 B634137078 B634137079 B634137080 B638137579 B638137585 B638137586 B638137592 B638137593 B642138043 B642138046 B642138048 B642138052 B642138055 B642138056 B642138058 B642138060 B642138062 B642138063 B642138065 B642138066 B642138068 B642138069 B642138070 B642138071 B642138072 B642138074 B642138075 B642138078 B642138082 B642138083 B642138084 B642138086 B642138087 B642138088 B642138089 B642138090 B642138091 B642138092 B642138095 B642138096 B642138098 B642138100 B642138101 B642138102 B642138103 B642138104 B642138106 B642138110 B642138111 B642138112 B600002899 B605148494 B605148497 B605148498 B605148502 B605148504 B605148505 B605148507 B605148508 B605148509 B605148512 B605148513 B605148514 B605148516 B605148517 B605148518 B605148519 B605148522 B605148524 B606148526 B606148528 B606148529 B606148532 B606148533 B606148535 B606148536 B606148537 B633137059 B638137549 B638137551 B638137557 B638137558 B638137560 B638137561 B638137563 B638137565 B638137566 B638137570 B638137577 B638137583 B638137588 B638137590 B638137591 B638137595…
FDA’s list runs to 11,417 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 11,417 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.