🔍 RecallPedia

Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW, IRC5PO2VAWL2, IRC5PO2VAWL3, IRC5PO2VAWL4, IRC5PO2VAWL5

Class I - Dangerous
🏥 Medical Devices Recalled: October 30, 2020 Invacare Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model numbers: IRC5PO2V from Serial # 14HF039890 to 18JF007415; IRC5PO2VC from Serial # 14IF004028 to 18JF028633; IRC5PO2VAW from serial #17HF030338-18IF018522; IRC5PO2VAWL2 from serial # 18BF007341-18IF024451; IRC5PO2VAWL3 from serial # 17JF002563-19AF008559; IRC5PO2VAWL5 from serial # 18EF003466-18EF003544. DI Number: 00841447100249
  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:
Invacare Corporation
Reason for Recall:
Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extinguishing fires or cap explosions.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW, IRC5PO2VAWL2, IRC5PO2VAWL3, IRC5PO2VAWL4, IRC5PO2VAWL5

Product Codes/Lot Numbers:

Model numbers: IRC5PO2V from Serial # 14HF039890 to 18JF007415; IRC5PO2VC from Serial # 14IF004028 to 18JF028633; IRC5PO2VAW from serial #17HF030338-18IF018522; IRC5PO2VAWL2 from serial # 18BF007341-18IF024451; IRC5PO2VAWL3 from serial # 17JF002563-19AF008559; IRC5PO2VAWL5 from serial # 18EF003466-18EF003544. DI Number: 00841447100249

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0514-2021

Related Recalls

DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR

Invacare

Class I - Dangerous

Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks and the Rollator can collapse causing injury to user

Jun 15, 2023 Other Medical Devices Nationwide View Details →