The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and…
Medical device recall Z-2738-2018. Published in FDA’s Enforcement Report on Aug 15, 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 Aug 15, 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
- 417 units 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 Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above.
417 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number1506-8600-000, Serial Numbers: CBRX00981 CBRX00984 CBRX00985 CBRX00988 CBRX00990 CBRX00438 CBRX00368 CBRX00369 CBRX01033 CBRX01043 CBRX01044 CBRX01048 CBRX01052 CBRX00201 CBRX00208 CBRX00209 CBRX00210 CBRX00212 CBRX00213…
Every code shown here, 1,993 characters
Model Number1506-8600-000, Serial Numbers: CBRX00981 CBRX00984 CBRX00985 CBRX00988 CBRX00990 CBRX00438 CBRX00368 CBRX00369 CBRX01033 CBRX01043 CBRX01044 CBRX01048 CBRX01052 CBRX00201 CBRX00208 CBRX00209 CBRX00210 CBRX00212 CBRX00213 CBRX00214 CBRX00215 CBRX00216 CBRX00217 CBRX00749 CBRX00750 CBRX01124 CBRX01131 CBRX01136 CBRX01160 CBRX01162 CBRX01163 CBRX01164 CBRX01165 CBRX01166 CBRX01169 CBRX01017 CBRX01042 CBRX01068 CBRX01069 CBRX01070 CBRX01071 CBRX01083 CBRX01090 CBRX01091 CBRX01097 CBRX01106 CBRX01107 CBRX01112 CBRX01115 CBRX01116 CBRX01117 CBRX01118 CBRX01122 CBRX01125 CBRX01126 CBRX01127 CBRX01128 CBRX01132 CBRX01133 CBRX01134 CBRX01135 CBRX01137 CBRX01151 CBRX01152 CBRX01159 CBRX00983 CBRX01061 CBRX01062 CBRX00266 CBRX00480 CBRX00484 CBRX00488 CBRX00490 CBRX00492 CBRX00346 CBRX00417 CBRX00418 CBRX00421 CBRX00444 CBRX00459 CBRX00505 CBRX00521 CBRX00534 CBRX00535 CBRX00548 CBRX00552 CBRX00553 CBRX00555 CBRX00570 CBRX00571 CBRX00587 CBRX00627 CBRX00629 CBRX00348 CBRX00349 CBRX00350 CBRX00365 CBRX00416 CBRX00471 CBRX00481 CBRX00485 CBRX00486 CBRX00487 CBRX00489 CBRX00510 CBRX00511 CBRX00512 CBRX00561 CBRX00562 CBRX00325 CBRX00326 CBRX00327 CBRX01167 CBRX00635 CBRX00203 CBRX00206 CBRX00222 CBRX00223 CBRX00224 CBRX00225 CBRX00226 CBRX00228 CBRX00229 CBRX00232 CBRX00253 CBRX00259 CBRX00260 CBRX00261 CBRX00642 CBRX01053 CBRX00359 CBRX00354 CBRX00367 CBRX00396 CBRW03703 CBRX00140 CBRX00155 CBRX00156 CBRX00158 CBRX00159 CBRX00160 CBRX00161 CBRX00162 CBRX00163 CBRX00164 CBRX00165 CBRX00166 CBRX00167 CBRX00168 CBRX00169 CBRX00171 CBRX00172 CBRX00176 CBRX00178 CBRX00179 CBRX00180 CBRX00181 CBRX00182 CBRX00183 CBRX00184 CBRX00185 CBRX00186 CBRX00187 CBRX00189 CBRX00191 CBRX00193 CBRX00194 CBRX00195 CBRX00199 CBRX00234 CBRX00267 CBRX00268 CBRX00270 CBRX00273 CBRX00277 CBRX00280 CBRX00281 CBRX00283 CBRX00286 CBRX00381 CBRX00393 CBRX00397 CBRX00399 CBRX00422 CBRX00427 CBRX00430 CBRX00432 CBRX00435 CBRX00463 CBRX00473 CBRX00476 CBRX00477 CBRX00478 CBRX00482 CBRX00493…
FDA’s list runs to 4,300 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) to: Washington, DC and countries of: Algeria, Bangladesh, Brazil, Chile, China, Colombia, Germany, Greece, Guatemala, Honduras, India, Indonesia, Iran, Iraq, Italy, Kenya, Lebanon, Malaysia, Maldives, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nigeria, Pakistan, Poland, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Tunisia, Turkey, United Arab Emirates, and Vietnam.
The states and territories these words name
- District of Columbia
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 Jun 28, 2018.
- FDA classified it on Aug 8, 2018.
- FDA’s Enforcement Report published it on Aug 15, 2018.
- FDA terminated it on Feb 22, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Datex-Ohmeda, Inc., of Madison, WI.
- 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 4,300 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.