Covidien Puritan Bennett 980 Ventilator — Class I medical device recall Z-0112-2015
Terminated recall by Nellcor Puritan Bennett Inc. (dba Covidien LP), reported 2014-11-05, distributed in CA, CO, FL, GA, KY, MA, MN, NC…. A software issue may lead to ventilator inoperative situations.
| Recall number | Z-0112-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP), Boulder, CO, United States |
| Recall initiated | 2014-10-01 |
| Classified | 2014-10-28 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2016-05-02 |
| Distributed | CA, CO, FL, GA, KY, MA, MN, NC, NY, OH, OK, PA, SC, TN, TX, UT, WI |
| Countries outside the US | AE, CA, MX, SA, ZA |
| Quantity | 324 units |
| Reason classes | software |
| Model numbers | 35B1400006, 35B1400007, 35B1400013, 35B1400015, 35B1400058, 35B1400066, 35B1400078, 35B1400079, 35B1400083, 35B1400089, 35B1400094, 35B1400099, 35B1400103, 35B1400106, 35B1400110, 35B1400112, 35B1400113, 35B1400114, 35B1400116, 35B1400118, 35B1400121, 35B1400124, 35B1400128, 35B1400129, 35B1400130 and 189 more |
Product
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Reason for recall
A software issue may lead to ventilator inoperative situations.
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-0112-2015. 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.