Recall Z-0233-2026— Baxter Healthcare Corporation

Name: FDA recall Z-0233-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-17

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2025-09-17. It names one FDA 510(k) clearance: K030580. 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. 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..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-09-17
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K030580 — SURETEMP PLUSWelch Allyn, Inc.·cleared 2003-05-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.