FDA recall Z-0847-2026

Baxter Healthcare Corporation · Class II · device

Product

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.

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.

Key facts

Status
Ongoing
Initiation date
2025-10-28
Report date
2025-12-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0847-2026