Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 -…
Medical device recall Z-0515-2021. Published in FDA’s Enforcement Report on Dec 9, 2020.
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 Dec 9, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 3217 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 firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, “Temperature Exceeds Limits” followed by automatic shutdown of the monitor with no accompanying alarm.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused.
3217, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers: SF16030134 SF16240121 SF16360313 SF16450067 SF17010227 SF17010247 SF17030358 SF17050642 SF17090981 SF17110474 SF17120491 SF17140419 SF17150846 SF17180407 SF17200722 SF17240406 SF18020067 SF18020101 SF18020103 SF18030281…
Every code shown here, 1,996 characters
Serial numbers: SF16030134 SF16240121 SF16360313 SF16450067 SF17010227 SF17010247 SF17030358 SF17050642 SF17090981 SF17110474 SF17120491 SF17140419 SF17150846 SF17180407 SF17200722 SF17240406 SF18020067 SF18020101 SF18020103 SF18030281 SF18090439 SF18090443 SF18110356 SF18271901 SF18271902 SF18271903 SF18271904 SF18271905 SF18271907 SF18271908 SF18271909 SF18271910 SF18271911 SF18271912 SF18271913 SF18271914 SF18271915 SF18271916 SF18271917 SF18271918 SF18271919 SF18271920 SF18271921 SF18271922 SF18271923 SF18271924 SF18271938 SF18271941 SF18280055 SF18301062 SF18420402 SF18430101 SF18430150 SF18430151 SF18430154 SF18430155 SF18430156 SF18430158 SF18430159 SF18430161 SF18430163 SF18430164 SF18430169 SF18430171 SF18430172 SF18430173 SF18430174 SF18430176 SF18430177 SF18430179 SF18430181 SF18430182 SF18430183 SF18430187 SF18430188 SF18430193 SF18430194 SF18430195 SF18430196 SF18430197 SF19250492 SF19260529 SF19330724 SF19470574 SF19480478 SF19480479 SF19480480 SF19480484 SF19480485 SF19480486 SF19480487 SF19480488 SF19480489 SF19480490 SF19480491 SF19480492 SF19480493 SF19480494 SF19480495 SF19480496 SF19480497 SF19480498 SF19480499 SF19480500 SF19480621 SF19480622 SF19480623 SF19480624 SF19480625 SF19480626 SF19480627 SF19480628 SF19480629 SF19480630 SF19480631 SF19480632 SF19480633 SF19480634 SF19480635 SF19480636 SF19480637 SF19480638 SF19480639 SF19480640 SF19480641 SF19480642 SF19480643 SF19480644 SF19480645 SF19480646 SF19480647 SF19480648 SF19480649 SF19480650 SF19480651 SF19480652 SF19480653 SF19480654 SF19480655 SF19480656 SF19480658 SF19480659 SF19480660 SF19480661 SF19480662 SF19480663 SF19480664 SF19480665 SF19480666 SF19480667 SF19480668 SF19480669 SF19480670 SF19480671 SF19480672 SF19480673 SF19480674 SF19480675 SF19480677 SF19480678 SF19480679 SF19480680 SF19480681 SF19480682 SF19480683 SF19480684 SF19480685 SF19480686 SF19480687 SF19480688 SF19480689 SF19480690 SF19480692 SF19480693 SF19480694 SF19480695 SF19480696 SF19480697 SF19480698 SF19480699…
FDA’s list runs to 44,588 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.
Worldwide distribution - US Nationwide distribution.
These words name no state.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Nov 16, 2020.
- FDA classified it on Dec 1, 2020.
- FDA’s Enforcement Report published it on Dec 9, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Covidien Llc, of Mansfield, MA.
- 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 44,588 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.