Medical device recalls Moderate risk

Baxter Healthcare Corporation recalls Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn T…

Recall date
October 28, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0847-2026
FDA classification
Class II
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
US Nationwide distribution in the states of California, Colorado, Ohio, and Utah.

Why it was recalled

Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.

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 INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.

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