Puritan Bennett 980 Series Ventilator, 980U3ESDIUU

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 - 10884521201545 Serial Numbers: 35B1700548 35B1700551 35B1700560 35B1700572 35B1700577 35B1700603 35B1700606 35B1700615
  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, 980U3ESDIUU

Product Codes/Lot Numbers:

GTIN/UDI - 10884521201545 Serial Numbers: 35B1700548 35B1700551 35B1700560 35B1700572 35B1700577 35B1700603 35B1700606 35B1700615

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0344-2022

Related Recalls

Due to customer complaint regarding incorrect display box labeling.

Apr 15, 2026 Other Medical Devices Nationwide View Details →

Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.

Jan 30, 2026 Diagnostic Equipment Nationwide View Details →