Puritan Bennett 980 Series Ventilator Recall Due to Assembly Error
Covidien LLC is recalling 278 Puritan Bennett 980 Series Ventilators due to a capacitor assembly error that may cause the device to become inoperable during use. Affected devices were distributed worldwide with specific serial numbers targeted.
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 recall is classified as Severe because the FDA designated it as a Class I recall, which mandates a minimum severity score of 4 per the rubric. No deaths or serious injuries have been reported in the source text, preventing a Critical rating, but the Class I classification confirms the potential for serious patient harm.
Plain-English summary
Covidien LLC is recalling 278 Puritan Bennett 980 Series Ventilators (model 980X3JADIJJ) due to a manufacturing assembly error. A capacitor within the device was assembled incorrectly, which may cause the ventilator to become inoperable during use.
This is a Class I medical device recall, indicating potential for serious patient harm. The affected devices were distributed worldwide, including throughout the United States. The recall specifically targets 11 serial numbers ranging from 35B1700393 to 35B1800002.
Healthcare facilities and users with affected serial numbers should immediately discontinue use of the device and contact Covidien LLC for information regarding replacement or repair. The FDA has designated this as a Class I recall due to the potential for device failure during critical patient use.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator, 980X3JADIJJ
- Manufacturer
- Covidien Llc
- 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 · assembly defect
See all →- ModerateOctopus Evolution Tissue Stabilizer Model TS2000 tubing assembly error
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- ModerateCardiosave battery charging station left bay screw prevents full battery insertion
FDA (Devices) · 2026-03-25
- HighMedtronic tissue stabilizer recalled after tubing was assembled in reverse
FDA (Devices) · 2026-03-04
Similar recalls
- SeverePuritan Bennett 980 Ventilator Recalled for Battery Overheating Risk
FDA (Devices) · 2020-11-18
- SevereCOVIDIEN Recalls Puritan Bennett 980 Ventilators Due to Software Update Issues
FDA (Devices) · 2018-12-26
- HighPuritan Bennett 560 Ventilator Recalled for Loss of Gas Supply
FDA (Devices) · 2022-09-28
- SevereFDA Recalls 324 Puritan Bennett 980 Ventilators Due to Software Issue
FDA (Devices) · 2014-11-05
- SevereCovidien Recalls Puritan Bennett 980 Ventilators Due to Capacitor Failure
FDA (Devices) · 2014-12-17
- HighPuritan Bennett 980 Ventilator Batteries Recalled for Firmware Defect
FDA (Devices) · 2018-04-04