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 | Potential missing segments on the display that can result in misinterpretation of data. |
| Product | OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate. |
| Quantity | 105,831 units |
| Distribution | Worldwide Distribution - US Nationwide including Canada. |
| Initiated | 2015-06-29 |
| Classified | 2015-07-27 |
| Terminated | 2017-11-03 |
| Recall number | Z-2268-2015 |
| 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-2268-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71583/
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