CAPNOSTREAM 20P (INTL) N - ROHS
Medical device recall Z-0039-2019. 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
- 264 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 - ROHS, Part Number CS08652-03
264, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
PA12170508 PA12170656 PA12170657 PA12170702 PA13170746 PA13170769 PA13170777 PA13170782 PA13170783 PA13170786 PA13170787 PA13170798 PA14170801 PA14170802 PA14170803 PA14170807 PA14170808 PA14170811 PA14170812 PA14170813 PA14170814…
Every code shown here, 1,991 characters
PA12170508 PA12170656 PA12170657 PA12170702 PA13170746 PA13170769 PA13170777 PA13170782 PA13170783 PA13170786 PA13170787 PA13170798 PA14170801 PA14170802 PA14170803 PA14170807 PA14170808 PA14170811 PA14170812 PA14170813 PA14170814 PA14170815 PA14170816 PA14170817 PA14170818 PA14170819 PA14170820 PA14170821 PA14170822 PA14170823 PA14170824 PA14170825 PA14170826 PA14170827 PA14170828 PA14170829 PA14170830 PA14170831 PA14170832 PA14170833 PA14170834 PA14170835 PA14170836 PA14170837 PA14170838 PA14170839 PA14170840 PA14170841 PA14170842 PA14170843 PA14170844 PA14170845 PA14170846 PA14170847 PA14170848 PA14170849 PA14170850 PA14170851 PA14170852 PA14170853 PA14170854 PA14170855 PA14170856 PA14170857 PA14170858 PA14170859 PA14170860 PA14170861 PA14170862 PA14170863 PA14170864 PA14170865 PA14170866 PA14170867 PA14170868 PA14170869 PA14170870 PA14170871 PA14170872 PA14170873 PA14170874 PA14170875 PA14170876 PA14170877 PA14170878 PA14170879 PA15171049 PA15171050 PA15171051 PA15171053 PA15171054 PA15171055 PA15171056 PA15171057 PA15171058 PA15171059 PA22172143 PA23172302 PA23172307 PA23172308 PA23172310 PA23172311 PA23172312 PA23172313 PA23172314 PA23172315 PA23172316 PA23172317 PA23172318 PA23172319 PA23172320 PA23172321 PA23172322 PA23172323 PA23172324 PA23172325 PA23172326 PA23172327 PA23172328 PA23172330 PA23172331 PA23172332 PA23172333 PA23172334 PA23172335 PA23172336 PA23172337 PA23172338 PA23172341 PA23172342 PA23172343 PA23172344 PA23172346 PA23172347 PA23172348 PA23172349 PA23172350 PA23172351 PA23172352 PA23172353 PA23172354 PA23172355 PA23172356 PA23172357 PA23172358 PA23172359 PA23172360 PA23172361 PA23172362 PA23172363 PA23172364 PA23172365 PA23172366 PA23172367 PA23172368 PA23172369 PA23172370 PA23172372 PA23172373 PA23172374 PA23172375 PA23172376 PA23172377 PA23172378 PA23172379 PA23172380 PA23172381 PA23172382 PA23172383 PA23172384 PA23172385 PA23172386 PA23172388 PA23172389 PA23172390 PA23172391 PA23172392 PA23172393 PA23172394 PA23172395 PA23172396…
FDA’s list runs to 2,903 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 2,903 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.