Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers
type: Dataset
description: FDA recall Z-0233-2026 — Baxter Healthcare Corporation is recalling Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers (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: Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers
  type: MedicalDevice
  manufacturer: Baxter Healthcare Corporation
claims: enforcement-record
claims: FDA classified recall Z-0233-2026 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0233-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0233-2026
      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: Baxter Healthcare Corporation
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-09-17
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Product code 01690-200, Serial Numbers 24518445 24518446 24518447 24518448 24518449 24518450 24518451 24518452 24518453 24518454 24518455 24518456 24518457 24518458 24518459 24518460 24518461 24518462 24518463 24518464 24518465 24518466 24518467 24518468 24518469 24518470 24518471 24518472 24518473 24518474 24518475 24518476 24518477 24518478 24518479 24518480 24518481 24518482 24518483 24518484 24518485 24518486 24518487 24518488 24518489 24518490 24518491 24518492 24518493 24518494 24518495 24518496 24518497 24518498 24518499 24518500 24518501 24518502 24518503 24518504 24518505 24518506 24518507 24518508 24518509 24518510 24518511 24518512 24518513 24518514 24518515 24518516 24518517 24518518 24518519 24518520 24518521 24518522 24518523 24518524 24518525 24518526 24518527 24518528 24518529 24518530 24518531 24518532 24518533 24518534 24518535 24518536 24518537 24518538 24518539 24518540 24518541 24518542 24518543 24518544 24518545 24518546 24518547 24518548 24518549 24518550 24518551 24518552 24518553 24518554 24518555 24518556 24518557 24518558 24518559 24518560 24518561 24518562 24518563 24518564 24518565 24518566 24518567 24518568 24518569 24518570 24518571 24518572 24518573 24518574 24518575 24518576 24518577 24518578 24518579 24518580 24518581 24518582 24518583 24518584 24518585 24518586 24518587 24518588 24518589 24518590 24518591 24518592 24518593 24518594 24518595 24518596 24518597 24518598 24518599 24518600 24518601 24518602 24518603 24518604 24518605 24518606 24518607 24518608 24518609 24518610 24518611 24518612 24518613 24518614 24518615 24518616 24518617 24518618 24518619 24518620 24518621 24518622 24518623 24518624 24518625 24518626 24518627 24518628 24518629 24518630 24518631 24518632 24518633 24518634 24518635 24518636 24518637 24518638 24518639 24518640 24518641 24518642 24518643 24518644 24518645 24518646 24518647 24518648 24518649 24518650 24518651 24518652 24518653 24518654 24518655 24518656 24518657 24518658 24518659 24518660 24518661 24518662…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Distribution US nationwide, Canada and Colombia.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-0233-2026: Baxter Healthcare Corporation is recalling Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers
text: The FDA logged enforcement record Z-0233-2026: Baxter Healthcare Corporation is voluntarily recalling Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers — reason: Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-17. Affected lots/codes: Product code 01690-200, Serial Numbers 24518445 24518446 24518447 24518448 24518449 24518450 24518451 24518452 24518453 24518454 24518455 24518456 24518457 24518458 24518459 24518460 24518461 24518462 24518463 24518464 24518465 24518466 24518467 24518468 24518469 24518470 24518471 24518472 24518473 24518474 24518475 24518476 24518477 24518478 24518479 24518480 24518481 24518482 24518483 24518484 24518485 24518486 24518487 24518488 24518489 24518490 24518491 24518492 24518493 24518494 24518495 24518496 24518497 24518498 24518499 24518500 24518501 24518502 24518503 24518504 24518505 24518506 24518507 24518508 24518509 24518510 24518511 24518512 24518513 24518514 24518515 24518516 24518517 24518518 24518519 24518520 24518521 24518522 24518523 24518524 24518525 24518526 24518527 24518528 24518529 24518530 24518531 24518532 24518533 24518534 24518535 24518536 24518537 24518538 24518539 24518540 24518541 24518542 24518543 24518544 24518545 24518546 24518547 24518548 24518549 24518550 24518551 24518552 24518553 24518554 24518555 24518556 24518557 24518558 24518559 24518560 24518561 24518562 24518563 24518564 24518565 24518566 24518567 24518568 24518569 24518570 24518571 24518572 24518573 24518574 24518575 24518576 24518577 24518578 24518579 24518580 24518581 24518582 24518583 24518584 24518585 24518586 24518587 2451858…
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-0233-2026 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.