CARESCAPE ONE
Medical device recall Z-0454-2026. Published in FDA’s Enforcement Report on Nov 19, 2025.
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 Nov 19, 2025. 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
- 5935 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?
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001
5935, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI 00195278288639 Serial numbers SV925270018SA SV925270014SA SV925270015SA SV925260105SA SV925270020SA SV925270013SA SV925270017SA SV925270016SA SV925060394SA SV925080329SA SV925080345SA SV925080323SA SV925080348SA SV925080153SA…
Every code shown here, 1,997 characters
UDI-DI 00195278288639 Serial numbers SV925270018SA SV925270014SA SV925270015SA SV925260105SA SV925270020SA SV925270013SA SV925270017SA SV925270016SA SV925060394SA SV925080329SA SV925080345SA SV925080323SA SV925080348SA SV925080153SA SV925080340SA SV925080281SA SV925080346SA SV925290119SA SV925290090SA SV925180134SA SV925160111SA SV925180131SA SV925180139SA SV925180140SA SV925180142SA SV925180143SA SV925180151SA SV925180152SA SV925160114SA SV925180141SA SV925180126SA SV925180132SA SV925180136SA SV925180135SA SV925180144SA SV925180146SA SV925180149SA SV925270007SA SV925260094SA SV925270009SA SV925270010SA SV925270008SA SV925260111SA SV925270003SA SV925270011SA SV925260085SA SV925260113SA SV925270001SA SV925270002SA SV925270006SA SV925270012SA SV925270005SA SV925270004SA SV925190002SA SV925180193SA SV925100151SA SV925100149SA SNA24400063SA SV925190009SA SV925200017SA SV925200028SA SV925190021SA SV925200022SA SV925200008SA SV925200015SA SV925200016SA SV925200021SA SV925200023SA SV925190014SA SV925200013SA SV925200012SA SV925200018SA SNA24162829SA SV925290115SA SV925220285SA SV925220291SA SV925220275SA SV925220267SA SV925220311SA SV925220240SA SV925220280SA SV925210129SA SV925220304SA SV925220255SA SV925220273SA SV925220288SA SV925210198SA SV925220281SA SV925220295SA SV925210171SA SV925220241SA SV925220290SA SV925210156SA SV925210165SA SV925210164SA SV925210163SA SV925210168SA SV925210137SA SV925210131SA SV925210141SA SV925190017SA SV925210136SA SV925210152SA SV925210162SA SV925210135SA SV925210149SA SV925210146SA SV925210126SA SV925210088SA SV925210139SA SV925150104SA SV925210158SA SV925060273SA SV925210145SA SV925210114SA SV925210166SA SV925220233SA SV925210115SA SV925210144SA SV925210153SA SV925210147SA SV925220262SA SV925220248SA SV925200025SA SV925220251SA SV925220282SA SV925220279SA SV925220246SA SV925220252SA SV925220284SA SV925210155SA SV925220254SA SV925220258SA SV925220274SA SV925220283SA SV925220287SA SV925220245SA SV925220242SA SV925220289SA SV925220272SA…
FDA’s list runs to 83,212 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 - 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 Sep 26, 2025.
- FDA classified it on Nov 7, 2025.
- FDA’s Enforcement Report published it on Nov 19, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare Finland Oy, of Helsinki, Finland.
- 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 83,212 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.