Capnostream20 (US) M
Medical device recall Z-0028-2019. 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
- 769 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, Part Number CS08653
769, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
B300001095 B300001167 B300001179 B300001180 B300001201 B300001203 B300001215 B300001216 B300001218 B300001195 B300001228 B300001364 B300001448 B300001407 B500001573 B500001539 B500001547 B500001548 B500001550 B500001553 B500001559…
Every code shown here, 1,991 characters
B300001095 B300001167 B300001179 B300001180 B300001201 B300001203 B300001215 B300001216 B300001218 B300001195 B300001228 B300001364 B300001448 B300001407 B500001573 B500001539 B500001547 B500001548 B500001550 B500001553 B500001559 B500001563 B500001567 B500001571 B500001580 B500001581 B500001582 B500001583 B500001588 B500001592 B500001502 B500001503 B500001506 B500001515 B500001519 B500001523 B500001525 B500001528 B500001529 B500001533 B500001538 B300001446 B500001478 B500001507 B500001518 B500001530 B500001561 B500001568 B500001569 B500001587 B300001360 B300001373 B300001441 B300001500 B500001501 B500001450 B500001461 B500001479 B500001481 B500001484 B500001485 B500001486 B500001487 B500001491 B500001493 B500001494 B500001495 B500001496 B500001497 B500001542 B500001543 B300001268 B500001362 B500001383 B500001399 B500001482 B500001489 B500001490 B500001492 B500001498 B500001537 B500001544 B500001504 B500001513 B500001514 B300001405 B500001540 B500001541 B500001650 B500001651 B500001677 B300001409 B500001663 B500001684 B500001685 B500001602 B500001648 B500001656 B500001661 B500001662 B500001667 B500001669 B500001671 B500001672 B500001673 B500001676 B500001678 B500001679 B500001681 B500001682 B500001686 B500001687 B500001689 B500001691 B500001692 B500001694 B500001699 B500001714 B500001724 B500001751 B500001752 B500001755 B500001756 B500001758 B500001775 B500001779 B500001782 B500001783 B500001785 B500001791 B500001745 B500001747 B500001760 B500001697 B500001726 B500001737 B500001668 B500001883 B500001893 B500001912 B500001769 B500001776 B500001778 B500001784 B500001787 B300001293 B300001355 B500001696 B500001664 B500001675 B500001695 B500001702 B500001704 B500001705 B500001712 B500001716 B500001719 B500001725 B500001733 B500001739 B500001709 B300001160 B300001161 B300001290 B300001297 B500001707 B500001718 B500001575 B300001112 B300001162 B300001163 B300001171 B300001287 B300001311 B500001703 B500001720 B500001708 B500001710 B500001734 B500001740 B500001741…
FDA’s list runs to 8,458 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 8,458 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.