Capnostream20 (US) M W/PRINTER TO MASIMO
Medical device recall Z-0031-2019. 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
- 400 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?
Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751
400, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
B500002176 B500002177 B500002186 B500002191 B500002192 B500002194 B500002199 B500002201 B500002202 B500002204 B500002205 B500002206 B500002207 B500002208 B500002209 B500002210 B500002211 B500002212 B500002213 B500002214 B500002215…
Every code shown here, 1,991 characters
B500002176 B500002177 B500002186 B500002191 B500002192 B500002194 B500002199 B500002201 B500002202 B500002204 B500002205 B500002206 B500002207 B500002208 B500002209 B500002210 B500002211 B500002212 B500002213 B500002214 B500002215 B500002216 B500002217 B500002218 B500002219 B500002220 B500002224 B500002225 B500002228 B500002229 B500002233 B500002236 B500002239 B500002240 B500002241 B500002245 B500002249 B500002250 B500002251 B500002252 B500002256 B500002258 B500002259 B500002261 B500002262 B500002265 B500002269 B500002270 B500002271 B500002272 B500002273 B500002274 B500002276 B500002277 B500002278 B500002279 B500002280 B500002281 B500002282 B500002283 B500002284 B500002285 B500002286 B500002287 B500002288 B500002291 B500002292 B500002293 B500002294 B500002295 B500002297 B500002298 B500002300 B500002301 B500002170 B500002234 B500002260 B500002266 B500002267 B500002296 B500002350 B500002351 B500002352 B500002353 B500002355 B500002356 B500002358 B500002359 B500002360 B500002361 B500002362 B500002363 B500002365 B500002366 B500002369 B500002371 B500002372 B500002395 B500002409 B500002410 B500002413 B500002414 B500002417 B500002419 B500002420 B500002421 B500002422 B500002423 B500002424 B500002425 B500002427 B500002428 B500002433 B500002438 B500002441 B500002442 B500002445 B500002452 B500002453 B500002454 B500002457 B500002460 B500002462 B500002463 B500002263 B500002264 B500002268 B500002289 B500002290 B500002299 B500002357 B500002364 B500002429 B500002430 B500002431 B500002432 B500002435 B500002443 B500002446 B500002498 B500002503 B500002510 B500002524 B500002533 B500002551 B500002583 B500002590 B500002591 B500002593 B500002447 B500002513 B500002392 B500002436 B500002437 B500002451 B500002456 B500002461 B500002464 B500002466 B500002467 B500002468 B500002473 B500002475 B500002480 B500002483 B500002490 B500002492 B500002506 B500002514 B500002439 B500002440 B500002455 B500002465 B500002561 B500002562 B500002302 B500002617 B500002618 B500002619 B500002620 B500002621…
FDA’s list runs to 4,399 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 4,399 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.