The recall stems from how the device itself was designed, rather than a manufacturing mistake. The FDA lists 218 recalls with this root cause since 2025, 32 of them Class I (most serious). Most recent report: Oct 7, 2026.
Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire.…
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting…
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting…
Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire.…
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting…
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting…
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting…
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting…
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.