FDA Device recall Z-1565-2025
Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2
- FDA Device
- Class II
- ongoing
- Published 2025-04-23
On 2025-04-23 the FDA classified a Class II recall of Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2 by Baxter Healthcare, citing undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1565-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-21 |
| Published | 2025-04-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | n/a |
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.
Identifiers
| code_info | 1) Product Code/Part # 44WT-2, UDI/DI 00732094309461; 2) Product Code/Part # 44WT-3, UDI/DI 00732094309454; 3) Produc…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1565-2025%22
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