GE Infant Resuscitation System Recall: Parents of child we experienced oxygen deprivation at birth, hypoxia, asphyxia, encephalopathy, respiratory distress, respiratory failure, seizures, low apgar scores

There is nothing like the feeling right before the birth of your child. The simultaneous excitement and fear that follows nearly a year of waiting and preparing is unapparelled. Some parents’ hopes and dreams shatter when a doctor tells them there is a problem with the baby breathing. Parents who’s child experienced oxygen deprivation at birth, hypoxia, asphyxia, encephalopathy, respiratory distress, respiratory failure, seizures, or low apgar scores start their parenting journey in a potentially traumatic way.

Serious, life-long injuries from oxygen deprivation

Oxygen deprivation at birth, hypoxia, asphyxia, encephalopathy, respiratory distress, respiratory failure, seizures, or low apgar scores can lead to cerebral palsy, hypoxic-ischemic encephalopathy (HIE), seizure disorders, developmental delays, intellectual disabilities, and other lifelong impairments. In some cases, if a newborn receives insufficient oxygen during resuscitation, the resulting hypoxic injury may cause permanent neurological damage, including cerebral palsy, epilepsy, developmental delays, cognitive impairments, and other lifelong disabilities. Families facing this must understand what lies ahead, and explore the causes because they should not face them alone.

Causes of Oxygen deprivation at birth, hypoxia, asphyxia, encephalopathy, respiratory distress, respiratory failure, seizures, or low apgar scores can include medical malpractice or product liability. 

Sometimes healthcare providers fail to act or make mistakes during labor and delivery. This can result on a birth injury. At times, a product may fail to function as designed and be the cause. Either way, families who lose a baby or bring home a child who experienced this will have many questions and challenges ahead. Following is an example of one potential cause.

FDA Early Alert: GE HealthCare Infant Resuscitation Systems May Put Newborns at Risk of Hypoxia

Families rely on neonatal intensive care units (NICUs), labor and delivery departments, and newborn nurseries to have life-saving equipment ready when every second matters. FDA released an Early Alert involving certain GE HealthCare infant resuscitation systems that raises serious concerns. The concern is whether some devices may deliver the intended oxygen concentration during neonatal resuscitation—an issue that could place vulnerable newborns at risk of hypoxia and other catastrophic injuries. (U.S. Food and Drug Administration)

At KBD Attorneys, we represent individuals and families harmed by defective medical devices and catastrophic negligence. Our attorneys have served in leadership positions in major product liability and mass tort litigations across the country. (See, e,g, BioZorb Recall Lawsuits). Our attorneys have also handled complex birth injury and catastrophic injury cases involving lifelong neurological impairments. The exact injury this product allegedly caused is one we have dealt with several times. Thus, KBD is uniquely positioned to evaluate claims involving newborn oxygen deprivation and related injuries.

It is critical that families dealing with these injuries speak with lawyers who know how to work up a case like this. The attorney must have experience fighting top-notch, well-resourced attorneys to prove the product was defective. They must also know how to work-up a case to secure the millions of dollars it will cost over a lifetime to care for someone injured in these ways. Additionally, the attorney has to be able to navigated the complex world of FDA regulated products. KBD’s attorneys have unique experience in this regard. Learn more to see if this impacts your family and if we can help.

What Did the FDA Announce? The Safety Notice Concerning Giraffe6 Stand-Alone Infant Resuscitation System; Giraffe6 Warmer with Integrated Resuscitation System (iRes); Panda Warmer with Integrated Resuscitation System (iRes); and Panda Freestanding Warmer; Service Blender Includes Standoffs and Knob

On June 5, 2026, the FDA issued an Early Alert regarding certain GE HealthCare infant resuscitation systems and warmers equipped with an M1091607-R blender. According to the FDA, GE HealthCare notified customers that affected devices should be identified, removed from service, and corrected before continued use. (U.S. Food and Drug Administration)

The affected products include:

• Giraffe6 Stand-Alone Infant Resuscitation Systems
• Giraffe6 Warmers with Integrated Resuscitation Systems
• Panda Warmers with Integrated Resuscitation Systems
• Panda Freestanding Warmers
• Certain replacement blender assemblies (M1091607-R) (U.S. Food and Drug Administration)

The FDA has characterized the issue as a potentially high-risk device problem and is continuing to evaluate the situation. (U.S. Food and Drug Administration)

To Which GE Infant Resuscitation Systems and Warmers Does this Apply?

The genesis of this safety notice is that FDA became aware that GE HealthCare issued a letter to affected customers. It recommended Infant Resuscitation Systems and Warmers with a M1091607-R blender be corrected prior to continued use.

See here from FDA’s site for the Full List of Affected Blender Serial Numbers.

Why Is This Recall So Concerning?

Infant resuscitation systems are used when newborns require immediate respiratory support after birth. These devices help clinicians deliver controlled oxygen concentrations and ventilation during some of the most critical moments in neonatal care.

While the FDA’s Early Alert remains under review, any malfunction affecting oxygen delivery during neonatal resuscitation can have devastating consequences because newborn brains are particularly sensitive to oxygen deprivation. Even relatively short periods of inadequate oxygenation can result in:

• Hypoxic-ischemic encephalopathy (HIE)
• Seizure disorders
• Cerebral palsy
• Developmental delays
• Cognitive impairments
• Motor deficits
• Permanent neurological injury
• Death in severe cases

Premature infants and medically fragile newborns may be especially vulnerable to complications from inadequate oxygen delivery. (U.S. Food and Drug Administration)

GE Has Faced Prior Infant Resuscitation Device Recalls

This is not the first time GE infant resuscitation systems have been associated with serious oxygen-delivery concerns. In a previous FDA Class I recall, GE Healthcare recalled certain Giraffe and Panda infant resuscitation systems after oxygen and air inlet fittings were reversed during assembly. The FDA warned that the defect could result in inaccurate oxygen regulation, potentially causing hypoxia (too little oxygen) or hyperoxia (too much oxygen), conditions that could lead to severe injury or death in newborns. (FDA Access Data).

A Class I recall is the FDA’s most serious recall classification and is reserved for situations where there is a reasonable probability that use of a device will cause serious adverse health consequences or death. (FDA Access Data)

The existence of prior oxygen-delivery issues involving similar neonatal resuscitation systems highlights why healthcare providers and families should pay close attention to this new FDA Early Alert.

What areHypoxia and Birth-Related Brain Injuries?

When a newborn’s brain does not receive adequate oxygen, brain cells can begin to suffer irreversible damage. The resulting injuries can vary significantly depending on:

• The duration of oxygen deprivation
• The severity of the oxygen deficit
• The infant’s gestational age
• How quickly effective treatment is provided
• Whether therapeutic hypothermia or other interventions are available

Many children who survive hypoxic brain injuries require lifelong medical care, including:

• Neurology treatment
• Physical therapy
• Occupational therapy
• Speech therapy
• Assistive technology
• Educational support services
• Future attendant care

Calculating these future needs often requires sophisticated life-care planning and testimony from multiple experts.

At KBD Attorneys, our experience handling catastrophic injury cases—including birth injury claims—allows us to work with nationally recognized experts who can evaluate the full extent of a child’s future medical, educational, and supportive care needs.

What Should Families Do?

If your child experienced complications during delivery, neonatal resuscitation, or shortly after birth, and was later diagnosed with:

• HIE
• Cerebral palsy
• Developmental delays
• Seizures
• Brain injury
• Significant neurological impairment

it may be important to determine:

1. Whether an affected GE infant resuscitation system was used.
2. Whether oxygen delivery problems occurred.
3. Whether device performance issues contributed to the injury.
4. Whether all applicable FDA and manufacturer guidance was followed.

Medical records, equipment logs, service records, and hospital investigations may all be important evidence. We can help you obtain the information to find out what caused this to happen to your little loved one.

KBD Attorneys Investigates Defective Medical Device Cases Nationwide

KBD Attorneys has represented clients in complex medical device litigation involving products such as hernia mesh, BioZorb, Cartiva, Impella heart pumps, pacemakers, orthopedic implants, and other medical technologies. Our lawyers have served in leadership and active roles in coordinated proceedings and mass tort litigations across the country.

We combine that product liability experience with extensive catastrophic injury litigation experience. We know how to support families through this process, We have decades of experience allowing us to evaluate not only how a device failed, but also how that failure affects a child and family over a lifetime. Most importantly, to working up a matter to assure long-term funding is recovered for the millions of dollars that can be necessary to care for a loved one with the conditions discussed herien.

If future investigations reveal that defective infant resuscitation equipment contributed to newborn injuries, families may need attorneys who understand both medical device litigation and the long-term consequences of hypoxic brain injuries.

Contact KBD Attorneys

The FDA has stated that it is continuing to review information related to this potentially high-risk device issue and will provide updates as additional information becomes available. (U.S. Food and Drug Administration)

If your child suffered a serious birth injury, hypoxic brain injury, HIE diagnosis, cerebral palsy, or other neurological complications following neonatal resuscitation, KBD Attorneys can help evaluate whether a defective medical device may have played a role.

Contact us confidentially at 855-KBA-LAWS (855-522-5297) or electronically.

Frequently Asked Questions

Can a Lack of Oxygen During Birth Cause Cerebral Palsy?

Yes. In some cases, a lack of oxygen to a baby’s brain before, during, or shortly after birth can cause permanent brain damage that results in cerebral palsy. Not all cases of cerebral palsy are caused by oxygen deprivation, but hypoxic-ischemic injuries are a recognized cause of the condition. The risk generally increases when oxygen deprivation is severe or prolonged. Birth injury lawyers work with these kinds of matters routinely.

Learn more from the Centers for Disease Control and Prevention (CDC) Cerebral Palsy Information Page and the National Institute of Neurological Disorders and Stroke (NINDS) Cerebral Palsy Resource.

What Happens If a Newborn Does Not Get Enough Oxygen?

When a newborn does not receive enough oxygen, cells throughout the body can be damaged. The brain is especially vulnerable because it requires a constant oxygen supply. Severe oxygen deprivation may result in hypoxic-ischemic encephalopathy (HIE), seizures, developmental delays, cerebral palsy, cognitive impairments, or death.

According to the National Institute of Child Health and Human Development (NICHD), oxygen deprivation around the time of birth can cause serious and sometimes permanent neurological injuries.

What Is Hypoxic-Ischemic Encephalopathy (HIE)?

Hypoxic-ischemic encephalopathy, commonly called HIE, is a type of brain injury caused by a lack of oxygen and blood flow to the brain. HIE can occur before, during, or shortly after birth and is one of the most serious complications associated with neonatal oxygen deprivation. Children with HIE may experience a wide range of outcomes, from mild developmental delays to severe disabilities requiring lifelong care.

For more information, visit the NICHD HIE Information Page and the Children’s Hospital of Philadelphia HIE Resource Center.

Can Defective Medical Equipment Cause Birth Injuries?

Yes. Defective medical devices, malfunctioning monitoring equipment, oxygen delivery systems, ventilators, and other neonatal care equipment can contribute to birth injuries if they fail to perform as intended. When a device provides inaccurate information or fails to deliver necessary treatment, a newborn may be placed at risk of serious complications. The FDA regularly monitors medical devices and issues recalls and safety communications when equipment may pose a risk to patients.

Visit the FDA Medical Device Safety Communications Page for additional information.

How Long Does a Baby Need to Be Without Oxygen to Suffer Brain Damage?

There is no universal answer. The amount of time required to cause brain damage depends on factors such as the degree of oxygen deprivation, blood flow to the brain, the infant’s overall health, and how quickly medical intervention occurs.

Medical experts generally agree that even relatively short periods of severe oxygen deprivation can cause permanent neurological injuries in newborns. Each case requires careful review by qualified medical experts. This is why experienced attorneys – ones who understand the medicine and science, can identify and retain top-notch professionals to serve as experts, and litigate the complex legal requirements in such cases is critical.

What Are the Signs of Oxygen Deprivation at Birth?

Parents may return home without knowing much about what happened. They may have heard some of the terms mentioned here. They may have just learned about the outcomes without much detail. Worse, some may not know anything and simply realize their baby is not developing as expected or see symptoms or changes in their babies.

Signs of oxygen deprivation may include:

• Low Apgar scores
• Difficulty breathing
• Need for resuscitation after birth
• Seizures
• Abnormal muscle tone
• Feeding difficulties
• Organ dysfunction
• Admission to a neonatal intensive care unit (NICU)

Some symptoms may appear immediately, while others may not become apparent until developmental milestones are missed months or years later.

Additional information is available from the American Academy of Pediatrics (AAP) Neonatal Care Resources.

What Causes Seizures in Newborn Babies?

Newborn seizures can have many causes, including oxygen deprivation, HIE, infections, metabolic disorders, stroke, bleeding in the brain, and certain genetic conditions.

Because seizures can be a sign of serious neurological injury, newborns who experience seizures often require extensive evaluation and monitoring.

The Boston Children’s Hospital Neonatal Seizure Information Page provides additional information about causes and treatment.

Can Birth Asphyxia Lead to Lifelong Disabilities?

Yes. Birth asphyxia can result in permanent injuries that affect a child’s physical, cognitive, and developmental abilities. Depending on the severity of the injury, a child may experience cerebral palsy, epilepsy, developmental delays, learning disabilities, vision impairments, hearing impairments, or other long-term challenges.

Many children with severe hypoxic injuries require ongoing medical care, therapy, educational support, assistive technology, and personal assistance throughout their lives.

The Cleveland Clinic Birth Asphyxia Overview and the CDC Developmental Disabilities Resources provide additional information.

Related Resources

If your family is concerned about injuries associated with a recalled medical device, learn more about KBD’s attorneys have worked in complex medical device litigation and complicated medical malpractice cases including birth injury. These cases often involve complex medical issues requiring experts in causation, life-care planning, rehabilitation medicine, neurology, and future economic damages.

This article is for informational purposes only and does not constitute legal advice. It concerns:

• infant resuscitation device recall
• newborn oxygen deprivation
• hypoxic ischemic encephalopathy (HIE)
• birth asphyxia
• oxygen deprivation at birth
• neonatal resuscitation injury
• cerebral palsy from oxygen deprivation
• GE Healthcare recall
• newborn brain injury
• HIE lawyer