CAPNOSTREAM 20P (US) N
Medical device recall Z-0021-2019. 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
- 1819 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, Part Number CS08651-01
1819, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
B632123514 B632123522 B633123527 B633123528 B646113021 B646113026 B646113035 B646113037 B646113040 B646113041 B632123520 B646113023 B646113028 B642138118 B642138121 B642138123 B642138125 B643138127 B643138129 B643138131 B643138133…
Every code shown here, 1,991 characters
B632123514 B632123522 B633123527 B633123528 B646113021 B646113026 B646113035 B646113037 B646113040 B646113041 B632123520 B646113023 B646113028 B642138118 B642138121 B642138123 B642138125 B643138127 B643138129 B643138131 B643138133 B643138135 B643138137 B643138138 B643138142 B643138143 B643138145 B643138147 B643138148 B643138157 B643138158 B643138159 B643138161 B643138163 B643138164 B646113029 B642138124 B643138149 B643138178 B643138184 B643138185 B643138188 B643138189 B643138194 B643138196 B643138197 B643138199 B643138200 B643138202 B643138203 B643138204 B643138205 B643138206 B643138207 B643138210 B643138211 B643138213 B643138214 B643138227 B643138229 B643138231 B643138234 B643138236 B643138237 B643138248 B644138275 B644138276 B644138280 B644138283 B644138288 B644138289 B644138290 B644138294 B645138308 B645138313 B645138319 B645138328 B645138330 B645138333 B645138334 B645138338 B645138343 B645138347 B645138368 B643138173 B643138180 B643138212 B643138223 B643138235 B643138244 B644138255 B644138257 B644138264 B644138270 B644138273 B644138274 B644138278 B644138279 B644138281 B644138282 B644138284 B644138285 B644138293 B644138295 B645138299 B645138301 B645138306 B645138307 B645138309 B645138310 B645138312 B645138315 B645138323 B645138325 B645138329 B645138332 B645138335 B645138342 B645138344 B645138345 B645138346 B645138348 B645138349 B645138350 B645138351 B645138354 B645138355 B645138357 B645138361 B645138362 B645138363 B645138370 B632123518 B642138117 B642138119 B643138130 B643138136 B643138140 B643138141 B643138152 B643138154 B643138162 B643138165 B643138176 B643138183 B643138193 B643138195 B643138198 B643138201 B643138208 B643138209 B643138220 B643138221 B643138226 B643138246 B643138247 B643138252 B644138260 B644138263 B644138267 B644138271 B644138277 B645138297 B645138300 B645138302 B645138303 B645138311 B645138322 B645138324 B645138326 B645138327 B645138331 B645138341 B645138360 B645138367 B646113043 B652138451 B652138452 B652138456 B652138457 B604148470…
FDA’s list runs to 20,008 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 20,008 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.