CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02
Medical device recall Z-0042-2019. 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
- 383 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 W/PRINTER - ROHS, CS08658-02
383, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
B819140013 B819140014 B819140015 B819140024 B819140030 B819140042 B819140044 B819140049 B820140072 B820140075 B820140077 B820140078 B820140079 B820140080 B820140081 B819140003 B819140005 B819140010 B819140016 B819140018 B819140023…
Every code shown here, 1,991 characters
B819140013 B819140014 B819140015 B819140024 B819140030 B819140042 B819140044 B819140049 B820140072 B820140075 B820140077 B820140078 B820140079 B820140080 B820140081 B819140003 B819140005 B819140010 B819140016 B819140018 B819140023 B819140025 B819140028 B819140029 B819140035 B819140036 B819140039 B819140047 B819140056 B819140059 B819140062 B820140067 B820140068 B820140071 B820140073 B820140074 B820140082 B819140009 B819140022 B819140027 B819140040 B819140041 B819140046 B819140053 B819140055 B819140057 B819140058 B819140061 B819140064 B819140066 B820140070 B839141804 B839141806 B839141810 B840141817 B840141841 B840141842 B840141836 B840141840 B840141845 B840141846 B848143029 B850143387 B851143493 B851143500 B851143504 B851143505 B851143534 B851143541 B851143548 B851143550 B851143553 B851143556 B851143566 B851143569 B851143578 B802153887 B802153892 B802153936 B802153947 B803153953 B802153812 B802153817 B802153834 B802153859 B802153879 B802153891 B802153903 B802153914 B802153940 B802153942 B803154038 B803154050 B804154170 B804154182 B804154191 B804154193 B804154199 B804154216 B804154245 B805154263 B805154265 B805154267 B851143580 B851143609 B851143638 B811155297 B811155312 B811155316 B811155317 B811155318 B811155324 B811155328 B811155330 B811155331 B811155332 B811155333 B811155334 B811155336 B811155340 B811155343 B802153855 B803153962 B804154095 B804154214 B804154246 B805154258 B805154264 B805154266 B805154271 B811155306 B811155320 B840141825 B842142222 B847142844 B851143537 B852143749 B852143771 B806154519 B812155486 B812155581 B812155588 B812155590 B812155598 B812155600 B812155619 B812155691 B812155696 B812155698 B812155700 B812155709 B812155715 B812155716 B812155721 B812155724 B812155726 B812155728 B812155732 B812155733 B812155737 B841141969 B850143455 P835150001 P835150002 P835150003 P835150004 P835150005 P835150006 P835150007 P835150008 P835150009 P835150010 P835150011 P835150012 P835150013 P835150014 P835150015 P835150016 P835150017 P835150018 P835150019…
FDA’s list runs to 4,212 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 4,212 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.