Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood… — Class II medical device recall Z-1567-2025
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-1567-2025 |
|---|---|
| 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 | 385,920 units |
| Reason classes | undeclared allergen |
| UPC / GTIN / UDI-DI | 00732094046755, 00732094071511, 00732094083170, 00732094083309, 00732094083347, 00732094083385, 00732094083965, 00732094084429, 00732094084498, 00732094084610, 00732094084924, 00732094085617, 00732094085631, 00732094085884, 00732094109603, 00732094109658, 00732094109726, 00732094109764, 00732094109801, 00732094109856, 00732094109900, 00732094110128 |
| Lot numbers | 24-314 |
| Model numbers | 407637, 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42, 7670-10, DS44-09, DS44-11, DS44-11C, DS44-MC, DS45-11, DS45-11C, DS45-12, DS45-MC, DS58-11, DS58-MC, DS58-PD, DS58-ST |
Product
Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, Product Code Part Numbers: 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42, DS44-09, DS44-11, DS44-11C, DS44-MC, DS45-11, DS45-11C, DS45-12, DS45-MC, DS58-11, DS58-MC, DS58-PD, DS58-ST; 2) WELCH ALLYN Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 407637; 3) WELCH ALLYN 767 Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 7670-10.
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-1567-2025. 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.