CAPNOSTREAM 20P (US) N - ROHS
Medical device recall Z-0022-2019. 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
- 10356 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 (US) N - ROHS, Part Number CS08651-02
10356, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
B836141101 B836141102 B836141103 B836141104 B836141106 B836141107 B836141108 B836141109 B836141110 B836141111 B836141113 B836141116 B836141117 B836141118 B836141119 B836141120 B836141121 B836141122 B836141123 B836141124 B836141125…
Every code shown here, 1,991 characters
B836141101 B836141102 B836141103 B836141104 B836141106 B836141107 B836141108 B836141109 B836141110 B836141111 B836141113 B836141116 B836141117 B836141118 B836141119 B836141120 B836141121 B836141122 B836141123 B836141124 B836141125 B836141126 B836141127 B836141128 B836141130 B836141131 B836141133 B836141134 B836141135 B836141136 B836141137 B836141138 B836141139 B836141140 B836141141 B836141142 B836141143 B836141144 B836141145 B836141146 B836141147 B836141148 B836141149 B836141150 B836141151 B836141152 B836141153 B836141154 B836141155 B836141156 B836141157 B836141158 B836141159 B836141160 B836141161 B836141162 B836141163 B836141164 B836141165 B836141166 B836141167 B836141169 B836141170 B836141172 B836141173 B836141174 B836141175 B836141176 B836141177 B836141105 B836141112 B836141179 B836141180 B836141181 B836141182 B836141184 B836141185 B836141186 B836141187 B836141188 B836141189 B836141190 B836141192 B836141193 B836141195 B836141197 B836141199 B836141200 B836141201 B836141203 B836141204 B836141205 B836141208 B836141211 B836141213 B836141215 B836141216 B836141219 B836141220 B836141227 B836141228 B837141233 B837141234 B837141235 B837141237 B837141240 B837141241 B837141242 B837141246 B837141247 B837141248 B837141249 B837141251 B837141252 B837141254 B837141256 B837141257 B837141259 B837141260 B837141262 B837141263 B837141264 B837141266 B837141268 B837141271 B837141273 B837141275 B837141276 B837141278 B837141280 B837141281 B837141283 B837141284 B837141286 B837141287 B837141290 B837141294 B837141297 B837141309 B837141311 B837141322 B836141178 B836141183 B836141224 B837141238 B837141243 B837141245 B837141250 B837141253 B837141265 B837141269 B837141274 B837141279 B837141282 B837141285 B837141288 B837141291 B837141296 B837141299 B837141300 B837141302 B837141303 B837141306 B837141308 B837141320 B837141323 B837141324 B837141329 B837141332 B837141334 B837141337 B837141347 B837141348 B837141351 B837141353 B837141364 B837141365 B837141366 B837141368 B837141372 B837141384…
FDA’s list runs to 121,557 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 121,557 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.