Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1 — Class II medical device recall Z-1568-2025
Ongoing recall by Baxter Healthcare Corporation, reported 2025-04-23. Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs
| Recall number | Z-1568-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2025-03-21 |
| Classified | 2025-04-15 |
| Reported by FDA | 2025-04-23 |
| Quantity | 76,407 units |
| Reason classes | undeclared allergen |
| UPC / GTIN / UDI-DI | 00732094002362, 00732094002379, 00732094002423, 00732094004182, 00732094004199, 00732094004380, 00732094004397, 00732094004472, 00732094108569, 00732094108583, 00732094109955, 00732094110494, 00732094111613, 00732094111644, 00732094111798, 00732094111811, 00732094111842, 00732094111873, 00732094111897, 00732094111996, 00732094112207, 00732094112221, 00732094112245, 00732094112276, 00732094112290 and 10 more |
| Lot numbers | 24-314 |
| Model numbers | 410519, 45-15-389, 45-22-189, 45-23-189, 4500-02, 4500-03, 47-15-389, 47-22-189, 47-23-189, 5082-01, 5082-01H, 5082-02, 5082-03, 5082-07, 5082-08, 5082-11, 5082-16, 5082-21, 5082-22, 5082-22H, 5082-23, 5082-23H, 5082-24, 5082-25, 5082-26 and 10 more |
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 for recall
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1568-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.