This week, the FDA issued a Safety Communication alerting the public of a recall by Philips Respironics. The company recalled certain respiratory BiPAP machines because they contain contaminated plastic. If the plastic gets in the motor, it may release harmful chemicals that should not be inhaled. The machine may also stop working.
What are BIPAP machines?
BiPAP machines help people breath by pumping air into the lungs at various pressure. They pump high pressure when inhaling and low pressure when exhaling. They are prescribed to people with respiratory insufficiency, respiratory failure, and sleep apnea.
What are the risks of inhaling the chemicals?
BiPAP users may suffer the following:
- respiratory tract irritations
- immune system reactions
- certain cancers
If the machine fails and stops working suddenly, it may lead to serious injury or death.
Which BiPAP machines are recalled?
The following models are included in the recall:
- A-Series BiPAP A30 (Ventilator)
- A-Series BiPAP A40 (Ventilator)
- A-Series BiPAP V30 (Auto Ventilator)
- OmniLab Advanced+
Philips Respironics sent Urgent Medical Device Recall letters to affected customers and suppliers. The letters list the exact serial numbers included in the recall.
What to do if you think your device has been recalled
If you think your BiPAP machine has been recalled, follow these steps:
- Confirm your device is recalled. Model numbers are listed on the FDA’s website and exact serial numbers are listed in the FDA’s Urgent Medical Device Recall letter.
- Consult your doctor to determine if your treatment should change.
- Report the problem to the FDA. The form can be found here.
The full Safety Communication can be found here.
Is this the same recall as last year?
No. In June 2021, the FDA recalled certain ventilators, BiPAP and CPAP machines manufactured by Philips Respironics. The machines at issue contain a polyester-based foam that reduces sound and vibration.
The recall occurred because the foam can break down. If it breaks down, pieces of foam or chemicals can be inhaled or swallowed. This may lead to serious injuries such as respiratory tract irritations, headaches, and certain cancers.
The recall is the subject of litigation. A multidistrict litigation (“MDL”) has been formed to manage the thousands of lawsuits filed against Philips Respironics and related entities for injuries sustained as a result of using the machines.
Information on that recall can be found here.