Hospitals across the country have been warned to immediately stop using certain Draeger mechanical ventilation filters after the U.S. Food and Drug Administration (FDA) issued a high-risk recall notice. The affected devices — SafeStar and TwinStar filters — are used during anesthesia and mechanical ventilation to prevent bacterial and viral contamination.
According to the FDA, the filters can cause misleading carbon dioxide readings during procedures. Carbon dioxide monitoring (capnography) is critical in surgery, particularly under anesthesia, as it helps ensure that a patient is ventilating properly. When readings are inaccurate, medical teams may administer unnecessary or harmful interventions — or fail to provide urgently needed care.
Scope of the Recall
The recall involves four models of Draeger filters, encompassing nearly 12 million devices used in operating rooms and intensive care units worldwide. The FDA classified the action in its highest risk category, noting that the defective filters have been linked to serious injuries. While no deaths have been reported, the potential consequences are severe, including:
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Airway injury
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Delayed or incorrect treatment
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Brain injury
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Death
Draeger began recalling the products in June 2025, and on July 22, the company issued updated instructions to immediately remove the devices from stock and return them for replacement.
Medical Malpractice Risks in Anesthesia Care
From a medical malpractice perspective, this recall raises significant concerns for anesthesia malpractice claims. Anesthesiologists and surgical teams are responsible for monitoring a patient’s vital signs and responding to changes in real time.
If a patient suffered harm because a healthcare provider relied on faulty readings without verifying their accuracy — or continued using a recalled device after the recall notice — both the device manufacturer and the medical professionals involved could face liability.
Hospitals have a legal and ethical duty to:
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Act promptly upon receiving recall notices
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Remove affected devices from use
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Implement alternative monitoring methods to ensure patient safety
Failure to do so could constitute negligence, potentially supporting a malpractice claim.
Holding Manufacturers and Providers Accountable
When a defective medical device causes injury, product liability law allows patients to hold the manufacturer accountable. But when medical teams also fail to take appropriate precautions, victims may have additional claims for medical malpractice.
Our attorneys have decades of experience handling complex product liability lawsuits and medical malpractice cases. We work with top medical experts to uncover how and why an injury occurred, identify all responsible parties, and fight for maximum compensation for our clients.
If you or a loved one suffered a serious injury during surgery or mechanical ventilation, it is critical to act quickly. Contact the experienced product liability and medical malpractice attorneys at Gair, Gair, Conason, Rubinowitz, Bloom, Hershenhorn, Steigman & Mackauf to discuss your legal options.
📞 Call 212-943-1090 for a free consultation or fill a form online.