BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S
type: Dataset
description: FDA recall Z-0457-2026 — GE Healthcare Finland Oy is recalling BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S
  type: MedicalDevice
  manufacturer: GE Healthcare Finland Oy
claims: enforcement-record
claims: FDA classified recall Z-0457-2026 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0457-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0457-2026
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: GE Healthcare Finland Oy
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: 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.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-09-26
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: No UDI Manufacturing date range (YYYY-MM-DD date format, located underneath date of manufacture symbol): 2024-11-25 - 2025-05-31; 2025-07-07 Serial Nos. 021725-20339 021725-22682 120924-06125 120924-05011 120924-05830 120924-03583 120924-04467 120924-04447 031425-28687 120924-04436 120924-04240 021725-21549 021725-20604 5567418-SO-1-1 031425-30157 031425-28597 031425-29489 031425-28901 031425-28978 031425-28590 031425-29484 031425-29177 021725-21521 021725-20357 021725-20412 021725-22331 120924-04465 120924-07616 120924-07484 120924-07792 120924-07909 120924-07359 120924-07524 120924-06997 120924-07861 120924-08477 120924-07878 120924-07726 120924-07799 120924-08618 120924-07791 120924-08527 120924-07862 120924-08616 120924-08622 031425-29009 031425-28366 031425-30139 031425-28758 031425-29924 031425-29879 031425-28136 031425-29340 031425-29934 031425-28144 031425-28970 031425-29883 031425-28120 031425-27976 031425-29349 031425-28713 031425-28188 021725-22330 021725-21579 021725-21271 021725-20338 021725-20573 021725-21576 021725-22607 021725-20579 021725-22599 021725-21251 010625-13475 021725-22701 120924-05740 031425-28162 031425-29868 031425-28705 031425-29295 031425-29944 031425-29899 022625-25420 022625-26187 022625-25158 022625-26232 022625-26208 022625-26814 022625-26256 022625-26220 022625-26867 022625-26890 031425-28985 031425-30149 120924-04966 120924-04244 120924-06139 120924-08030 120924-05493 120924-07728 120924-05393 120924-04387 120924-05428 120924-06013 120924-04841 120924-08550 120924-06003 120924-06135 120924-04210 021725-22415 031425-30066 031425-28908 031425-28289 031425-28010 031425-29583 031425-28980 031425-30088 031425-28467 031425-28402 031425-28164 031425-28699 031425-28036 031425-29029 031425-29593 031425-29205 031425-28994 031425-29211 031425-28425 031425-28051 031425-28130 031425-29646 031425-28424 031425-28446 031425-29630 031425-27842 031425-29012 031425-27815 031425-28055 031425-29897 031425-28768 031425-28749 031425-29054 031425-28157…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide - US Nationwide distribution.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-0457-2026: GE Healthcare Finland Oy is recalling BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S
text: The FDA logged enforcement record Z-0457-2026: GE Healthcare Finland Oy is voluntarily recalling BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S — reason: 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.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-26. Affected lots/codes: No UDI Manufacturing date range (YYYY-MM-DD date format, located underneath date of manufacture symbol): 2024-11-25 - 2025-05-31; 2025-07-07 Serial Nos. 021725-20339 021725-22682 120924-06125 120924-05011 120924-05830 120924-03583 120924-04467 120924-04447 031425-28687 120924-04436 120924-04240 021725-21549 021725-20604 5567418-SO-1-1 031425-30157 031425-28597 031425-29489 031425-28901 031425-28978 031425-28590 031425-29484 031425-29177 021725-21521 021725-20357 021725-20412 021725-22331 120924-04465 120924-07616 120924-07484 120924-07792 120924-07909 120924-07359 120924-07524 120924-06997 120924-07861 120924-08477 120924-07878 120924-07726 120924-07799 120924-08618 120924-07791 120924-08527 120924-07862 120924-08616 120924-08622 031425-29009 031425-28366 031425-30139 031425-28758 031425-29924 031425-29879 031425-28136 031425-29340 031425-29934 031425-28144 031425-28970 031425-29883 031425-28120 031425-27976 031425-29349 031425-28713 031425-28188 021725-22330 021725-21579 021725-21271 021725-20338 021725-20573 021725-21576 021725-22607 021725-20579 021725-22599 021725-21251 010625-13475 021725-22701 120924-05740 031425-28162 031425-29868 031425-28705 031425-29295 031425-29944 031425-29899 022625-25420 022625-26187 022625-25158 022625-26232 022625-26208 022625-26814 022625-26256 022625-26220 022625-26867 022625…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-0457-2026 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.