FDA Device recall Z-1568-2025
Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Pa…
- FDA Device
- Class II
- ongoing
- Published 2025-04-23
On 2025-04-23 the FDA classified a Class II recall of Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Pa… 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-1568-2025 |
| 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 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Part Numbers: 2. WELCH ALLYN Reusable Blood Pressure Cuff Kit, Product Code/Part Numbers: 410519, 5090-41, 5098-20.
Reason
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Identifiers
| code_info | 1) Product Code/Part # 47-15-389, UDI/DI 00732094002423; Product Code/Part # 47-22-189, UDI/DI 00732094002379; Produc…1) Product Code/Part # 47-15-389, UDI/DI 00732094002423; Product Code/Part # 47-22-189, UDI/DI 00732094002379; Product Code/Part # 47-23-189, UDI/DI 00732094002362; Product Code/Part # 5082-01, UDI/DI 00732094113723; Product Code/Part # 5082-01H, UDI/DI 00732094113693; Product Code/Part # 5082-02, UDI/DI 00732094113679; Product Code/Part # 5082-03, UDI/DI 00732094113648; Product Code/Part # 5082-07, UDI/DI 00732094113631; Product Code/Part # 5082-08, UDI/DI 00732094113600; Product Code/Part # 5082-11, UDI/DI 00732094113327; Product Code/Part # 5082-16, UDI/DI 00732094113105; Product Code/Part # 5082-21, UDI/DI 00732094112344; Product Code/Part # 5082-22, UDI/DI 00732094112290; Product Code/Part # 5082-22H, UDI/DI 00732094112276; Product Code/Part # 5082-23, UDI/DI 00732094112245; Product Code/Part # 5082-23H, UDI/DI 00732094112221; Product Code/Part # 5082-24, UDI/DI 00732094112207; Product Code/Part # 5082-25, UDI/DI 00732094111996; Product Code/Part # 5082-26, UDI/D |
|---|
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-1568-2025%22
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