Z-1565-2025 Class II Ongoing
FDA device recall Z-1565-2025 was initiated by Baxter Healthcare Corporation on Mar 21, 2025 and is designated Class II. Reason for recall: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. The recall status is ongoing. Affected quantity: 34187 units.
Recall details
- Product Type
- Devices
- Report Date
- Apr 23, 2025
- Initiation Date
- Mar 21, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34187 units
Product description
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 for recall
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Distribution pattern
Worldwide distribution.
Code information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1565-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026