Class II U.S. Food and Drug Administration

Baxter Healthcare Corporation Oral Probe , accessory used with Welch Allyn SureTemp recall: Affected oral/axillary probes were inadvertently programmed with the rectal

Recall published 12 months ago

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.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0233-2026
Published
October 29, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Baxter Healthcare Corporation
Product type
Medical devices
Units affected
5209
Distribution
Nationwide
Made in
United States
Lot / code info
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 24518663 24518664 24518665 24518666 24518667 24518668 24518669 24518670 24518671 24518672 24518673 24518674 24518675 24518676 24518677 24518678 24518679 24518680 24518681 24518682 24518683 24518684 24518685 24518686 24518687 24518688 24518689 24518690 24518691 24518692 24518693 24518694 24518695 24518696 24518697 24518698 24518699 24518700 24518701 24518702 24518703 24518704 24518705 24518706 24518707 24518708 24518709 24518710 24518711 24518712 24518713 24518714 24518715 24518716 24518717 24518718 24518719 24518720 24518721 24518722 24518723 24518724 24518725 24518726 24518727 24518728 24518729 24518730 24518731 24518732 24518733 24518734 24518735 24518736 24518737 24518738 24518739 24518740 24518741 24518742 24518743 24518744 24518745 24518746 24518747 24518748 24518749 24518750 24518751 24518752 24518753 24518754 24518755 24518756 24518757 24518758 24518759 24518760 24518761 24518762 24518763 24518764 24518765 24518766 24518767 24518768 24518769 24518770 24518771 24518772 24518773 24518774 24518775 24518776 24518777 24518778 24518779 24518780 24518781 24518782 24518783 24518784 24518785 24518786 24518787 24518788 24518789 24518790 24518791 24518792 24518793 24518794 24518795 24518796 24518797 24518798 24518799 24518800 24518801 24518802 24518803 24518804 24518805 24518806 24518807 24518808 24518809 24518810 24518811 24518812 24518813 24518814 24518815 24518816 24518817 24518818 24518819 24518820 24518821 24518822 24518823 24518824 24518825 24518826 24518827 24518828 24518829 24518830 24518831 24518832 24518833 24518834 24518835 24518836 24518837 24518838 24518839 24518840 24518841 24518842 24518843 24518844 24518845 24518846 24518847 24518848 24518849 24518850 24518851 24518852 24518853 24518854 24518855 24518856 24518857 24518858 24518859 24518860 24518861 24518862 24518863 24518864 24518865 24518866 24518867 24518868 24518869 24518870 24518871 24518872 24518873 24518874 24519158 24519159 24519160 24519161 24519162 24519163 24519164 24519165 24519166 24519167 …

Products covered by this recall

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

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • 02893-000
  • 01690-200
  • 01690-400

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Baxter Healthcare Corporation — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Baxter Healthcare Corporation — 1 Baxter Pkwy, Deerfield, IL, 60015-4625

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Baxter Healthcare Corporation medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number 02893-000, 01690-200, 01690-400. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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