# FDA recall Z-0425-2021

> **Covidien Llc** · Class II · device recall initiated 2020-10-16.

## Product

Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation  SKU:  980X1ENDIUU  980X1ENDIUU  980X3FRAIQC  980X3DEDRAC  980X3ENNISB  980X3NLDRAC  980X3PLDIPC  980X3ESDIEC  980X3ITDIEC  980X3JADIJJ  980X3SVAIQC  980U3ENASAA  980U1ENDICU  980U1FRDICU  980X3ENDRAC  980X1FRDISS  980A3ENNISB  980X1PLDIPC  980X3SKNISC  980U3ESDIUU  980X1DEDISS  980X3DEDISS  980X3HUNISC  980X3ENDIPP  980X1BGDRAC  980X1ENDRAC  980X1NLDRAC  980A1ENNISB  980X3TRDRAC  980X3CSNISC  980U3ESDIUC  980U1ENASAA  980X1JADIJJ  980X1FRAIQC  980X1ENDIPC  980X1ENNISB  980X1ESDIEC  980X1ITDIEC  980X1PTDIPC  980X1DEDRAC  980X1TRDRAC  980X3RODRAC  980S1ENDICU  980X3RUDRAC  980U1ESDIUU  980U3ESDIUA  980X3SRDRAC  980X1ENDIPP  980U1ESDIUC  980X3ENDIUU  980X3ENDIJI  980X1SKNISC  980X3PTDIPC  980U1ESDIUA  980U3PTDIUNA  980X1DAAGAC  980X1FIAGAC  980X1NOAGAC  980X1SVAGAC  980X3ENAIQC  980X1HUNISC  980X2EN

## Reason for recall

In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack,  create the risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm,

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Bolivia, Brazil, Cayman Islands, Chile,   Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Jamaica, Mexico, Nicaragua, Panama,   Peru, Uraguay, Honduras, Austria, Bahrain, Belgium, Bulgaria,   Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland,  France, Germany, Greece, Hungary, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Netherlands,   Norway, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Taiwan, Korea, Brunei Daruss.,   Cambodia, Indonesia, Malaysia, Singapore, Thailand, Vietnam,   Japan.

## Key facts

- **Recall number:** Z-0425-2021
- **Recalling firm:** Covidien Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-10-16
- **Report date:** 2020-11-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0425-2021

## Citation

> AI Analytics. FDA recall Z-0425-2021. Retrieved 2026-08-12 from https://api.ai-analytics.org/recall/Z-0425-2021. Source: US FDA. Licensed CC0.

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