CAPNOSTREAM 20 (INTL) N W/PRINTER
Medical device recall Z-0040-2019. 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
- 144 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 W/PRINTER, Part Number CS08658
144, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
B200001028 B200001034 B200001060 B200001022 B200001023 B200001038 B200001041 B200001042 B200001052 B200001054 B200001055 B200001056 B200001024 B200001039 B200001040 B200001049 B200001051 B200001058 B200001059 B200001026 B200001029…
Every code shown here, 1,583 characters
B200001028 B200001034 B200001060 B200001022 B200001023 B200001038 B200001041 B200001042 B200001052 B200001054 B200001055 B200001056 B200001024 B200001039 B200001040 B200001049 B200001051 B200001058 B200001059 B200001026 B200001029 B200001037 B200001031 B200001094 B200001033 B200001172 B200001228 B200001050 B200001459 B200001025 B400002243 B200001045 B200001047 B200001044 B200001138 B200001689 B200001832 B200001837 B200001854 B200001855 B200001645 B200001633 B200001917 B400002296 B400002401 B400002435 B400002444 B400002350 B400002453 B400002451 B400002454 B200001839 B200001573 B440112951 B440112966 B440112973 B417123382 B417123383 B417123387 B440112949 B417123381 B417123384 B417123386 B417123385 B410123238 B447123766 B447123768 B447123769 B448123792 B200002165 B411134508 B411134523 B411134459 B411134469 B440112945 B400002441 B416135016 B416135070 B400002237 B423135806 B423135807 B423135808 B423135811 B424135818 B424135821 B424135824 B424135828 B424135830 B424135832 B424135833 B424135835 B424135836 B424135839 B424135842 B424135843 B424135846 B424135848 B424135853 B424135856 B424135859 B424135861 B200001159 B428136417 B428136419 B428136423 B428136425 B428136427 B428136428 B428136431 B428136432 B428136438 B428136444 B428136445 B428136447 B428136455 B428136459 B428136462 B428136464 B428136466 B428136407 B428136408 B428136414 B428136418 B428136421 B428136422 B428136424 B428136426 B428136429 B428136434 B428136436 B428136441 B428136443 B428136446 B428136449 B428136450 B428136452 B428136456 B428136457 B428136458 B428136461 B428136463 B200001053 B407123203 B428136416
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.”
- 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.