Recall Z-0233-2026
Baxter Healthcare Corporation · initiated September 17, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: 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…
Reason for recall
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.
FDA-determined cause: Process control
Action taken
Beginning September 17, 2025, firm notified impacted distributors via Medical Device Recall letters. Customers were instructed to return any affected product and submit a request for replacements. Distributors were instructed to notify their end users via a provided Important Product Information Letter. For general questions regarding this action, please contact Welch Allyn technical service at 800-535-6663. Select the following sequence of options: 2 (technical support), 1(English), 1 (physical exam devices), 3 (thermometry), between the hours of 8:00 AM and 8:00 PM Eastern Time, Monday through Friday.
Details
- Recall number
- Z-0233-2026
- Initiated
- September 17, 2025
- Posted by FDA
- October 23, 2025
- Product code
- FLL – Continuous Measurement Thermometer
- Quantity
- 5209
- Distribution
- Distribution US nationwide, Canada and Colombia.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL