Class II
Medical Device Recall: 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.
Baxter Healthcare Corporation · October 28, 2025
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of California, Colorado, Ohio, and Utah.
States Affected
NATIONWIDE
Quantity Affected
118 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0847-2026
Status: ongoing
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