Medical device recalls Moderate risk

Welch Allyn Reusable Blood Pressure Cuff Kits labeled as: 1 recalled over undeclared natural

Recall date
March 21, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Baxter Healthcare Corporation recalls Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff K…
Recall number
Z-1568-2025
FDA classification
Class II
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
Worldwide distribution.

Why it was recalled

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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