Puritan Bennett 980 Series Ventilator Recalled for Manufacturing Defect
Covidien Llc is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing assembly error where a capacitor may have been installed incorrectly, potentially causing device inoperability during use.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: This is an FDA Class I recall, which establishes a minimum severity score of Severe (4). Although no illnesses or injuries have been reported, the manufacturing defect may cause device inoperability during use.
Plain-English summary
Covidien Llc is recalling 278 Puritan Bennett 980 Series Ventilators (Model 980S1ENDICU) due to a manufacturing assembly error where a capacitor may have been incorrectly installed. This defect may cause the ventilator to become inoperable during use.
The affected units have been distributed worldwide and throughout the United States. The recalled serial numbers are: 35B1700409, 35B1700443, 35B1700457, 35B1700462, 35B1700473, 35B1700476, 35B1700483, 35B1700487, 35B1700490, 35B1700511, 35B1700552, 35B1700567, 35B1700569, 35B1700570.
Anyone with one of these ventilators should check the serial number to determine if their device is affected.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator, 980S1ENDICU
- Manufacturer
- Covidien Llc
- Category
- Medical Device — Ventilator
- Affected units
- 278
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Covidien Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 16 products in this recall →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 · manufacturing defect
See all →- ModerateBoston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects
FDA (Devices) · 2026-10-28
- ModerateBoston Scientific Recalls Defective Direxion Torqueable Microcatheters
FDA (Devices) · 2026-10-28
- ModerateBoston Scientific Recalls Defective Direxion Torqueable Microcatheters
FDA (Devices) · 2026-10-28
- ModerateBoston Scientific Recalls Defective Direxion Torqueable Microcatheters
FDA (Devices) · 2026-10-28
- ModerateBoston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects
FDA (Devices) · 2026-10-28
Similar recalls
- SeverePuritan Bennett 980 Ventilator Recalled for Battery Overheating Risk
FDA (Devices) · 2020-11-18
- HighPuritan Bennett 560 Ventilator Recalled for Loss of Gas Supply
FDA (Devices) · 2022-09-28
- SevereCovidien Recalls Puritan Bennett 980 Ventilators Due to Capacitor Failure
FDA (Devices) · 2014-12-17
- SevereCOVIDIEN Recalls Puritan Bennett 980 Ventilators Due to Software Update Issues
FDA (Devices) · 2018-12-26
- SevereFDA Recalls 324 Puritan Bennett 980 Ventilators Due to Software Issue
FDA (Devices) · 2014-11-05
- HighPuritan Bennett 980 Ventilator Batteries Recalled for Firmware Defect
FDA (Devices) · 2018-04-04