Recall Z-0233-2026 ยท FLL Continuous Measurement Thermometer
Baxter Healthcare Corporation
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
| Date | Oct 23, 2025 (initiated Sep 17, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| 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 thro |
| Quantity | 5209 |
| Distribution | Distribution US nationwide, Canada and Colombia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030580 | SURETEMP PLUS Welch Allyn, Inc., May 6, 2003 |