FDA-Device2025-12-10Class IIMISBRANDING
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.
Hazard
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.
Who it affects
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of California, Colorado, Ohio, and Utah.
Affected count
118 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0847-2026More Baxter recalls
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- FDA-Device2026-07-08Baxter operating table head positioning adapter recalled for loosening risk
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT AC recalled for nebulizer cup leakage risk
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