Puritan Bennett 980 Series Ventilator, 980X3JADIJJ

Class I - Dangerous
🏥 Medical Devices Recalled: November 4, 2021 Covidien Patient Monitors Nationwide

What Should You Do?

  1. Check if you have this product:
    GTIN/UDI - 10884521172531 Serial Numbers: 35B1700393 35B1700419 35B1700420 35B1700427 35B1700428 35B1700429 35B1700540 35B1700564 35B1700568 35B1700573 35B1800002
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Covidien Llc
Reason for Recall:
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Puritan Bennett 980 Series Ventilator, 980X3JADIJJ

Product Codes/Lot Numbers:

GTIN/UDI - 10884521172531 Serial Numbers: 35B1700393 35B1700419 35B1700420 35B1700427 35B1700428 35B1700429 35B1700540 35B1700564 35B1700568 35B1700573 35B1800002

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0353-2022

Related Recalls

Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting

Jun 23, 2025 Diagnostic Equipment Nationwide View Details →