CAPNOSTREAM 20 (INTL) N
Medical device recall Z-0036-2019. 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
- 245 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 20 (INTL) N, Part Number CS08652
245, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
B200001301 B200001306 B200001625 B200002065 B200002206 B200001982 B200002098 B200001475 B200002000 B200001865 B200001835 B200001944 B200002030 B200002202 B200001012 B200001314 B200001866 B200002032 B200002139 B200001723 B200001908…
Every code shown here, 1,991 characters
B200001301 B200001306 B200001625 B200002065 B200002206 B200001982 B200002098 B200001475 B200002000 B200001865 B200001835 B200001944 B200002030 B200002202 B200001012 B200001314 B200001866 B200002032 B200002139 B200001723 B200001908 B200001926 B200001703 B200001755 B200001500 B200001763 B200001519 B200001653 B200001655 B200001661 B200001670 B200001722 B400001155 B400002342 B200001729 B400002520 B400002480 B400002505 B200001802 B400002492 B400002518 B400002521 B400002542 B400002728 B400002713 B400002800 B400002813 B451113083 B450113072 B406123152 B406123163 B408123213 B400002450 B410123265 B420123420 B420123421 B400002844 B440112971 B447123778 B449123886 B449123889 B449123899 B449123915 B449123917 B449123919 B449123920 B449123921 B449123922 B449123924 B449123925 B449123927 B449123930 B449123931 B449123936 B449123938 B449123939 B449123963 B449123967 B450123979 B450123982 B450123983 B450123985 B450123989 B450123991 B450123994 B450123995 B450123998 B450123999 B450124000 B450124001 B450124003 B451124006 B415123322 B420123441 B445123646 B448123832 B405134172 B405134174 B408134285 B408134293 B408134300 B409134335 B409134341 B409134366 B409134370 B409134372 B409134373 B409134374 B410134375 B410134376 B410134377 B410134378 B410134379 B410134380 B410134381 B410134383 B410134384 B410134385 B410134386 B410134388 B410134389 B410134390 B410134391 B410134392 B410134393 B410134395 B410134396 B410134397 B410134398 B410134399 B410134402 B410134403 B410134404 B410134406 B410134407 B410134408 B410134409 B410134410 B410134412 B410134413 B409134371 B410134456 B411134457 B411134458 B411134460 B411134461 B411134463 B411134464 B411134465 B411134467 B411134470 B411134472 B411134473 B411134475 B411134477 B411134478 B411134479 B411134480 B411134481 B411134482 B411134483 B411134484 B411134487 B411134488 B411134490 B411134492 B411134493 B411134495 B411134496 B411134497 B411134498 B411134499 B411134501 B411134502 B415123331 B411134468 B412134577 B412134579 B412134580 B413134639 B413134664…
FDA’s list runs to 2,694 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 2,694 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.