Capnostream 35 Portable Respiratory Monitor — Class II medical device recall Z-0515-2021
Ongoing recall by Covidien Llc, reported 2020-12-09, distributed nationwide. The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a
| Recall number | Z-0515-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien Llc, Mansfield, MA, United States |
| Recall initiated | 2020-11-16 |
| Classified | 2020-12-01 |
| Reported by FDA | 2020-12-09 |
| Distributed | Nationwide (US) |
| Quantity | 3,217 |
| Reason classes | software |
| Serial numbers | SF16030134, SF16240121, SF16360313, SF16450067, SF17010227, SF17010247, SF17030358, SF17050642, SF17090981, SF17110474, SF17120491, SF17140419, SF17150846, SF17180407, SF17200722, SF17240406, SF18020067, SF18020101, SF18020103, SF18030281, SF18090439, SF18090443, SF18110356, SF18271901, SF18271902 and 475 more |
Product
Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused.
Reason for recall
The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed by automatic shutdown of the monitor with no accompanying alarm.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0515-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.