Capnostream20 M NICU (CPM), CS08654RN
Medical device recall Z-0046-2019. 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
- 262 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 M NICU (CPM), CS08654RN
262, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
B300001035 B300001077 B300001081 B300001085 B300001086 B300001088 B300001054 B300001067 B300001073 B300001087 B300001026 B300001041 B300001058 B300001062 B300001078 B300001079 B300001080 B300001083 B300001084 B300001089 B300001090…
Every code shown here, 1,992 characters
B300001035 B300001077 B300001081 B300001085 B300001086 B300001088 B300001054 B300001067 B300001073 B300001087 B300001026 B300001041 B300001058 B300001062 B300001078 B300001079 B300001080 B300001083 B300001084 B300001089 B300001090 B300001091 B300001173 B300001175. B300001217 B300001055 B300001059 B300001134 B300001143 B300001150 B300001151 B300001152 B300001157 B300001174 B300001175 B300001194 B300001197 B300001199 B300001206 B300001209 B300001211 B300001223 B300001225 B300001149 B300001226 B300001227 B300001072 B300001093 B300001153 B300001154 B300001186 B300001192 B300001221 B300001155 B300001156 B300001193 B300001222 B300001305 B300001338 B300001340 B300001345 B300001346 B300001347 B300001348 B300001349 B300001350 B300001353 B300001358 B300001365 B300001367 B300001369 B300001371 B300001374 B300001379 B300001380 B300001382 B300001390 B300001391 B300001401 B300001406 B300001213 B300001240 B300001378 B300001413 B300001414 B300001415 B300001416 B300001417 B300001419 B300001420 B300001421 B300001424 B300001426 B300001428 B300001429 B300001431 B300001434 B300001435 B300001436 B300001437 B300001438 B300001440 B300001442 B300001444 B300001447 B300001451 B300001457 B300001463 B300001433 B500001557 B500001536 B500001560 B500001564 B300001159 B300001243 B300001272 B300001279 B300001357 B300001361 B300001368 B300001376 B300001381 B300001385 B300001395 B300001499 B300001196 B300001322 B300001329 B300001333 B300001337 B300001351 B300001356 B300001387 B300001403 B500001480 B500001483 B300001286 B300001306 B300001307 B300001410 B300001411 B500001597 B500001598 B500001599 B500001600 B500001601 B500001603 B500001604 B500001605 B500001606 B500001608 B500001609 B500001610 B500001611 B500001612 B500001613 B500001614 B500001615 B500001616 B500001617 B500001618 B500001619 B500001620 B500001621 B500001622 B500001623 B500001624 B500001625 B500001626 B500001627 B500001628 B500001629 B500001630 B500001631 B500001632 B500001633 B500001634 B500001635 B500001636 B500001637 B500001638…
FDA’s list runs to 2,882 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 2,882 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.