CAPNOSTREAM 20P (US) N W/PRINTER - ROHS
Medical device recall Z-0025-2019. 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
- 2806 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 - ROHS, Part Number CS08657-02
2806, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
B819140007 B819140026 B819140032 B819140038 B819140050 B819140051 B819140052 B819140054 B819140060 B819140063 B820140069 B839141801 B839141803 B840141814 B840141819 B840141820 B840141823 B840141826 B839141802 B839141805 B839141807…
Every code shown here, 1,991 characters
B819140007 B819140026 B819140032 B819140038 B819140050 B819140051 B819140052 B819140054 B819140060 B819140063 B820140069 B839141801 B839141803 B840141814 B840141819 B840141820 B840141823 B840141826 B839141802 B839141805 B839141807 B839141808 B839141809 B839141811 B839141812 B839141813 B840141815 B840141816 B840141818 B840141821 B840141822 B840141824 B840141827 B840141828 B840141829 B840141830 B840141831 B840141832 B840141833 B840141834 B840141835 B840141837 B840141838 B840141839 B840141843 B840141844 B840141847 B840141848 B840141849 B840141850 B819140004 B819140006 B819140008 B819140011 B819140012 B819140017 B819140020 B819140021 B819140031 B819140033 B819140037 B819140043 B819140045 B819140048 B819140034 B841142048 B844142441 B844142455 B845142604 B847142950 B848143034 B848143039 B848143043 B848143053 B848143084 B848143096 B848143104 B849143117 B849143118 B849143120 B849143121 B849143122 B849143123 B849143124 B849143130 B849143168 B849143233 B849143252 B849143253 B849143274 B850143302 B850143306 B850143342 B850143395 B850143417 B850143433 B850143434 B850143435 B850143436 B850143437 B850143438 B850143442 B850143465 B850143469 B850143473 B850143474 B851143476 B851143480 B851143481 B851143482 B851143483 B851143484 B851143485 B851143486 B851143494 B851143495 B851143496 B851143497 B851143498 B851143499 B851143501 B851143502 B851143503 B851143506 B851143507 B851143508 B851143509 B851143510 B851143511 B851143512 B851143513 B851143514 B851143515 B851143516 B851143517 B851143518 B851143519 B851143520 B851143522 B851143523 B851143524 B851143525 B851143526 B851143527 B851143528 B851143529 B851143530 B851143531 B851143532 B851143533 B851143535 B851143536 B851143538 B851143539 B851143540 B851143542 B851143543 B851143544 B851143545 B851143546 B851143547 B851143549 B851143551 B851143552 B851143554 B851143555 B851143557 B851143558 B851143559 B851143560 B851143561 B851143562 B851143563 B851143564 B851143565 B851143568 B851143570 B851143571 B851143572 B851143574 B851143575…
FDA’s list runs to 30,866 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 30,866 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.