Recall archive / FDA device enforcement
Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 4... — FDA record Z-1565-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 21, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.
- Reason
- Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 34187 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1565-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1) Product Code/Part # 44WT-2, UDI/DI 00732094309461; 2) Product Code/Part # 44WT-3, UDI/DI 00732094309454; 3) Product Code/Part # 44WT-4, UDI/DI 00732094309447; 4) Product Code/Part # 44WT-6, UDI/DI 00732094309423; 5) Product Code/Part # 44WT-B, UDI/DI 00732094309409; 6) Product Code/Part # 44XT-2, UDI/DI 00732094309386; 7) Product Code/Part # 44XT-4, UDI/DI 00732094309362; 8) Product Code/Part # 44XT-6, UDI/DI 00732094309348; 9) Product Code/Part # 44XT-B, UDI/DI 00732094309324; Lot Number 24-314 & lower |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 23, 2025
- Recall initiation date
- Mar 21, 2025
- Center classification date
- Apr 15, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.