Class II — Covidien LP (formerly Nellcor Puritan Bennett Inc.)
| Recalling firm | Covidien llc |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances. Covidien Respiratory and Monitoring Solutions, now a part of Medtronic, issued a field corrective action notice for two issues on all models of Puritan Bennett 980 (PB980) ventilator. |
| Product | Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation. |
| Quantity | 1,864 units |
| Distribution | Worldwide Distribution -- US, including but not limited to the territory of Puerto Rico; and Ireland, Jordan, Saudi Arabia, Bahrain, Australia, Japan, Israel, Turkey, Chile, South Africa, Costa Rica, United Arab Emirates, Qatar, Peru, Panama, Singapore, Kuwait, Lebanon, Brazil, Mexico, Colombia, Russia, Uruguay, Slovenia, Morocco, Argentina, Egypt, and Romania. |
| Initiated | 2016-01-15 |
| Classified | 2016-03-16 |
| Terminated | 2017-07-11 |
| Recall number | Z-1181-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Covidien LP (formerly Nellcor Puritan Bennett Inc.) (Z-1181-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73096/
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