An FDA-recorded root-cause determination. The FDA lists 117 recalls with this root cause since 2025, 3 of them Class I (most serious). Most recent report: Sep 30, 2026.
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years.…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years.…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years.…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years.…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years.…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years.…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years.…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years.…
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.