Medline Neonatal and Pediatric Endotracheal Tube Injury Lawsuit Lawyers

Nationwide Legal Help for Families Harmed by Recalled Medline Infant Breathing Kits Containing Smiths Medical Endotracheal Tubes

Medline Infant Breathing Kit Recall: A Life-Threatening Risk for Newborns and Children

The U.S. Food and Drug Administration (FDA) has issued a Class I recall, its most urgent category, for multiple neonatal and pediatric intubation kits distributed by Medline. These kits, used in hospitals and emergency medical settings, include endotracheal tubes manufactured by Smiths Medical that were found to be too small, resulting in inadequate ventilation for the youngest and most vulnerable patients.

These recalled devices are used in critical, often life-saving procedures to help newborns and children breathe during emergencies or routine medical interventions. When a tube is too small to allow proper airflow, the consequences can be devastating. According to FDA reports, at least eight infants suffered serious injuries as a result of these devices, although no deaths have been reported at this time.

The risks of inadequate airway management in newborns and children include:

• Hypoxia (oxygen deprivation)
• Brain damage
• Cardiac arrest
• Organ failure
• Long-term neurological complications

If your child was injured during intubation or required resuscitation in a hospital or neonatal setting and complications occurred, you may be eligible to file a medical device injury lawsuit. Our law firm is currently accepting cases related to the Medline breathing kit recall and is committed to helping families secure justice and financial compensation.

The Cause of the Recall: Faulty Endotracheal Tubes in Medline Kits

The problem stems from a design defect in the Smiths Medical endotracheal tubes included in various Medline neonatal and pediatric “convenience kits.” These devices are intended to keep the airway open in infants and children who cannot breathe adequately on their own.

However, the endotracheal tubes included in these recalled kits were discovered to be too small, making it difficult or impossible for sufficient airflow to reach the lungs during critical moments of care. In the most urgent cases, this could cause immediate respiratory failure or the need for emergency intervention.

The recall was prompted by eight reported injuries and the extreme risk of catastrophic complications like permanent brain damage or death from asphyxiation. Recognizing the gravity of the hazard, the FDA issued a Class I recall, which is reserved only for products that present a serious threat to health or life.

These kits were widely distributed and used in both emergency and non-emergency settings, including labor and delivery wards, neonatal intensive care units (NICUs), and pediatric hospitals across the country. Suppose your child suffered oxygen deprivation, needed unplanned resuscitation, or experienced any respiratory emergency during or after intubation. In that case, it is crucial to review whether one of these recalled kits was involved.

List of Recalled Medline Neonatal and Pediatric Kits

The FDA and Medline have released the following product information for the recalled kits. If your child was treated with one of these, it may form the basis of a personal injury or wrongful death claim:

• NEONATAL INTUBATION TRAY– ACC010371C
• NEWBORN RESUSCITATION KIT– ACC010381A, ACC010381B, ACC010381C
• PEDS GREY-PINK-RED– ACC010395
• PEDS PURPLE– ACC010397
• NEONATAL INTUBATION TRAY– ACC010541A, ACC010541B, ACC010541C
• PEDIATRICS INTUBATION TRAY– DYNJAA252

Each of these kits contains a defective breathing tube that has now been linked to life-threatening complications in clinical use. The manufacturer has requested that all kits be immediately removed from use and destroyed. Healthcare providers were notified by Medline on April 4, 2025, with detailed instructions on isolation and destruction protocols.

If your child underwent a procedure involving one of these kits around or after that date—or if your medical provider failed to act on the recall—you may also have a failure to warn or medical negligence claim in addition to a product liability lawsuit.

Potential Injuries Caused by Faulty Infant Endotracheal Tubes

The danger of using an improperly sized endotracheal tube in newborns or children cannot be overstated. These tubes are used during time-sensitive respiratory support, and any limitation in airflow can quickly spiral into irreversible harm. Some of the most common and severe injuries associated with defective intubation in neonates and children include:

• Hypoxic-Ischemic Encephalopathy (HIE): Brain injury caused by a lack of oxygen and blood flow.
• Seizures: A sign of acute neurological damage following oxygen deprivation.
• Cardiopulmonary Arrest: Often requiring extended resuscitation and resulting in multi-organ failure.
• Lung Damage or Collapse: Improper airflow can lead to pressure trauma or uneven ventilation.
• Developmental Delays: Brain injuries suffered in infancy can lead to long-term cognitive and physical impairments.

Any of these complications can permanently alter a child’s life—and deeply impact their family’s future. If your child was affected, filing a lawsuit may not only provide financial support for medical costs and long-term care, but also hold the responsible parties accountable.

Who May Be Eligible to File a Lawsuit

If your infant or child suffered a medical emergency involving respiratory failure, unexpected intubation issues, or oxygen deprivation during treatment, and that treatment involved one of the Medline neonatal or pediatric kits listed in the recall, you may be entitled to file a product liability or medical malpractice claim.

Qualifying cases may involve:

• Emergency procedures involving a recalled Medline kit
• Neonatal resuscitation complications with documented breathing issues
• Delays in ventilation or failed intubation requiring emergency surgery
• Diagnoses of brain injury or developmental delays after intubation
• Medical records indicating the use of Smiths Medical endotracheal tubes in Medline kits

Even if your child survived, ongoing medical monitoring or treatment for neurological symptoms may be required. Lawsuits can recover costs related to past and future medical care, special education needs, therapy, pain and suffering, and, in tragic cases, funeral and burial expenses.

How to File a Medline Neonatal Breathing Kit Lawsuit

Filing a medical device lawsuit can be daunting for any parent, especially while navigating your child’s recovery. At Parker Waichman LLP, we handle every detail for you. If you believe a recalled Medline breathing kit contributed to your child’s injury, here are the recommended steps:

1. Gather Medical Records – Obtain hospital or treatment center records from the date of your child’s intubation or emergency care. This may include procedure logs, resuscitation documentation, and discharge summaries.
2. Identify the Product Used – If possible, request documentation from the hospital to confirm whether a Medline kit was used and whether the product code matches one of the recalled lots.
3. Contact Our Law Firm – Our team will review your case for free, gather supporting evidence, and, if your claim qualifies, file a lawsuit on your behalf. We also assist in identifying and preserving additional evidence, including hospital correspondence and internal recall memos.
4. Pursue Compensation – A lawsuit may result in financial recovery for medical expenses, lost income (if a parent needed to leave work to care for the child), pain and suffering, emotional distress, and long-term care costs.

Parker Waichman LLP Is Accepting Medline Pediatric Injury Cases Nationwide

As a national civil litigation law firm, Parker Waichman LLP has long stood beside families harmed by defective medical devices and hospital negligence. We are actively investigating cases involving Medline neonatal and pediatric intubation kits and are here to provide a free, no-obligation legal review for any parent whose child suffered during or after intubation.

We understand the trauma of having your child harmed by a product that was supposed to help save their life. Legal action can provide the resources your family needs to move forward while helping to prevent similar incidents in the future.

Contact Parker Waichman LLP For a Free Case Review

If your infant or child suffered respiratory failure, brain injury, or other complications during intubation or emergency treatment, you may be eligible for compensation. The recalled Medline neonatal and pediatric intubation kits have already harmed multiple children—and your family may be entitled to justice.

Call Parker Waichman LLP today at 1-800-YOUR-LAWYER (1-800-968-7529) to speak with a legal team experienced in defective medical device lawsuits. We are offering free consultations nationwide to families affected by these dangerous medical devices. There are no legal fees unless we win your case. Protect your child’s future and find out your rights today. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.