CAPNOSTREAM 20 (US) N W/PRINTER
Medical device recall Z-0024-2019. 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
- 1798 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 (US) N W/PRINTER, Part Number CS08657
1798, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
B20001115 B20001127 B200001151 B200001164 B200001206 B200001211 B200001254 B200001201 B200001180 B200001220 B200001236 B200001337 B200001179 B200001246 B200001261 B200001268 B200001293 B200001207 B200001242 B200001215 B200001217 B200001219…
Every code shown here, 2,000 characters
B20001115 B20001127 B200001151 B200001164 B200001206 B200001211 B200001254 B200001201 B200001180 B200001220 B200001236 B200001337 B200001179 B200001246 B200001261 B200001268 B200001293 B200001207 B200001242 B200001215 B200001217 B200001219 B200001247 B200001262 B200001380 B200001213 B200001421 B200001433 B200001442 B200001457 B200001464 B200001523 B200001465 B200001216 B200001455 B200001529 B200001619 B200001621 B200001623 B200001629 B200001649 B200001662 B200001676 B200001504 B200001390 B200001393 B200001575 B200001724 B200001941 B200001988 B200002012 B200002043 B200002084 B200002086 B200002118 B200002193 B400001903 B400002063 B400002083 B400002123 B400002177 B400002212 B400002216 B400002239 B200001804 B200002124 B200002052 B400002241 B400002246 B400002247 B400002254 B400002256 B400002228 B400002245 B400002251 B400002252 B200002127 B200002140 B200002152 B200002155 B200002157 B200001777 B400002026 B400002174 B400002191 B200001959 B200002011 B200002039 B200002044 B200002046 B200002169 B200002160 B200002170 B200002192 B200002201 B200002207 B400002146 B400002217 B400002230 B400002233 B200002037 B200002040 B200001173 B200001284 B200001361 B200001366 B200001401 B200001416 B200001440 B200001454 B200001513 B200001628 B200002057 B200002059 B400002021 B400002141 B400002215 B200001226 B200001234 B200001302 B200001317 B200001356 B200001363 B200001426 B200001713 B200001732 B200001764 B200001776 B200001814 B200001942 B200002004 B200002015 B200002017 B200002023 B200002055 B200002064 B200002069 B200002071 B200002072 B400002208 B400002209 B400002218 B400002225 B200001794 B200001811 B200001971 B200002020 B200002113 B200001851 B200001902 B200001979 B200001208 B200001488 B200001490 B200001491 B200001493 B200001494 B200001512 B200001782 B200001787 B200001820 B200001748 B200001828 B200001758 B200001339 B200001447 B200001797 B200001841 B200001859 B200001860 B200001478 B200001846 B200001668 B200001718 B200001735 B200001109 B200001706 B200001816 B200001822 B200001907 B200001927 B200001656…
FDA’s list runs to 19,775 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 19,775 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.