Puritan Bennett 980 Ventilator Recalled for Battery Overheating Risk
Covidien is recalling Puritan Bennett 980 ventilators due to battery overheating and thermal damage risks that could cause burns or smoke exposure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of burns and bronchospasm from smoke or hazardous materials, which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Puritan Bennett 980 (PB980) Ventilator Series manufactured by Covidien LLC. The recall involves 23,329 units distributed worldwide, including 12,956 units in the United States and 10,405 units in other countries.
The recall was initiated due to in-house laboratory observations and customer reports of overheating and/or thermal damage to the battery pack. This defect creates a risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm for patients or healthcare providers.
Affected units are identified by specific serial numbers listed in the FDA recall record Z-0425-2021. Healthcare facilities and users should check their inventory against the provided serial number list and contact the manufacturer or FDA for instructions on corrective actions.
The recalled product
- 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…
- Manufacturer
- Covidien Llc
- Category
- Medical Device — Ventilator
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Covidien Llc
See all →- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- ModerateCovidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
- ModerateCovidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
Same hazard · burn injury
See all →- SevereVQQQ Gas Patio Heaters Recalled for Fire and Burn Hazards
CPSC · 2026-10-22
- SevereSteris Recalls RAPICIDE PA High-Level Disinfectant Due to Pressure Hazard
FDA (Devices) · 2026-10-21
- HighThomas Built Buses Recalls 2027 Saf-T-Liner C2 School Buses
NHTSA · 2026-10-21
- SevereDR Power Trimmer Mowers Recalled for Fire and Burn Hazards
CPSC · 2026-10-08
- SevereHyundai and Genesis Recall Vehicles Due to Front Seat Fire Risk
NHTSA · 2026-10-08
Similar recalls
- SeverePuritan Bennett 980 Series Ventilator Recalled for Manufacturing Assembly Defect
FDA (Devices) · 2021-12-15
- SeverePuritan Bennett 980 Series Ventilator Recall Due to Manufacturing Defect
FDA (Devices) · 2021-12-15
- CriticalPuritan Bennett 980 Series Ventilators Recalled for Incorrect Capacitor Assembly
FDA (Devices) · 2021-12-15
- SeverePuritan Bennett 980 Series Ventilator recalled for assembly defect
FDA (Devices) · 2021-12-15
- SeverePuritan Bennett 980 Series Ventilator Recall Due to Assembly Error
FDA (Devices) · 2021-12-15
- SeverePuritan Bennett 980 Ventilators Recalled Due to Manufacturing Assembly Error
FDA (Devices) · 2021-12-15