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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
- ModerateCovidien Mon-a-Therm general purpose temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
Same hazard · assembly defect
See all →- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution Tissue Stabilizer Model TS2000 tubing assembly error
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