FDAMarch 25, 2022device
Puritan Bennett 980 Series Ventilator
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.
What to do
FDA enforcement status: Ongoing
Brands named
medtronic formerly covidienmedtronicmedtronic formerly
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMedtronic O-arm O2 Imaging System. Model Number: BI70002000.2026-05-19
- FDAMedtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor2026-05-13
- FDAMedtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor2026-05-13
- FDAOctopus Evolution AS Tissue Stabilizer, Model TS25002026-05-12
- FDAOctopus Evolution Tissue Stabilizer, Model TS20002026-05-12
- FDAOctopus 4 Tissue Stabilizer, Model 294002026-05-12
- FDACovidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 900502026-04-23
- FDACovidien Mon-a-Therm General Purpose Temperature Probe REF: 900442026-04-23
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