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

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.