Puritan Bennett 980 Series Ventilator Recall Due to Manufacturing Defect
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing error where a capacitor was assembled incorrectly, which may cause the device to become inoperable during use.
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 is classified as an FDA Class I recall. The FDA's rules establish that Class I recalls never score below 4, as they indicate potential for serious injury or death. Although no injuries or deaths have been reported, the risk that a ventilator may become inoperable during use poses a serious patient safety hazard.
Plain-English summary
The Puritan Bennett 980 Series Ventilator (model 980S3ENDICU) is being recalled by Covidien LLC due to a manufacturing assembly error involving a capacitor. The defect may cause the ventilator to become inoperable during use.
Approximately 278 units have been distributed worldwide, including throughout the United States. The affected units are identified by serial numbers 35B1700406, 35B1700449, 35B1700467, 35B1700469, 35B1700471, 35B1700474, 35B1700481, 35B1700526, and 35B1700558.
Healthcare facilities and individuals using affected ventilators should immediately contact Covidien for guidance on device replacement or repair. Patients dependent on this device should consult with their healthcare provider to ensure alternative respiratory support is available.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator, 980S3ENDICU
- 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 esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien Mon-a-Therm general purpose temperature probes 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 error
See all →- ModerateKnee fusion nail components recalled over a locking screw inserted backwards
FDA (Food) · 2025-12-17
- HighMiniaturized TEE probes recalled over reversed articulation from assembly error
FDA (Devices) · 2025-10-15
- ModeratePhasor neurosurgical drills may have a reverse battery orientation
FDA (Devices) · 2025-08-06
- SevereMedline Fluid Delivery Sets incorrectly assembled with wrong drip chamber
FDA (Devices) · 2025-01-22
- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03