The FDA has posted 6 enforcement recalls of blood pressure cuff devices since 2025, none of them Class I (most serious). Most recent report: Dec 10, 2025.
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.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Blood Pressure Cuff”). Informational only — verify against the FDA before acting.