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Open, Classified

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

FDA Recall Z-0233-2026 · Posted 2025-10-23

Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeFLL
Date Initiated2025-09-17
Product Quantity5209

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.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Distribution US nationwide, Canada and Colombia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030580SURETEMP PLUSWelch Allyn, Inc. · 2003-05-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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