Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 0169
FDA device recall Z-0233-2026 · posted 2025-10-23 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- 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.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FLL
- Quantity affected
- 5209
- Distribution
- Distribution US nationwide, Canada and Colombia.
- Date initiated
- 2025-09-17
- Date posted
- 2025-10-23
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURETEMP PLUS (K030580) | Welch Allyn, Inc. | 2003-05-06 |