Hearth Record

Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes…

Medical device recall Z-0233-2026. Published in FDA’s Enforcement Report on Oct 29, 2025.

FDA’s own record, on accessdata.fda.gov

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 Oct 29, 2025. Copied from openFDA on Oct 20, 2026.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

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.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

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

5209, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

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…

Every code shown here, 1,992 characters

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…

FDA’s list runs to 46,999 characters. The first part is shown; the rest is on FDA’s record.

Source:

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.

Distribution US nationwide, Canada and Colombia.

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.

Source:

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Sep 17, 2025.
  • FDA classified it on Oct 23, 2025.
  • FDA’s Enforcement Report published it on Oct 29, 2025.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Baxter Healthcare Corporation, of Deerfield, IL.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

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 46,999 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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