This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Products
Product Name |
Product Code |
UDI |
|---|---|---|
NEONATAL INTUBATION TRAY |
ACC010371C |
10193489268188 |
NEWBORN RESUSCITATION KIT |
ACC010381A |
10193489800944 |
NEWBORN RESUSCITATION KIT |
ACC010381B |
10193489457803 |
NEWBORN RESUSCITATION KIT |
ACC010381C |
10193489922127 |
PEDS GREY-PINK-RED |
ACC010395 |
10193489218152 |
PEDS PURPLE |
ACC010397 |
10193489218169 |
NEONATAL INTUBATION TRAY, |
ACC010541A |
10195327036980 |
NEONATAL INTUBATION TRAY |
ACC010541B |
10195327153649 |
NEONATAL INTUBATION TRAY |
ACC010541C |
10198459155765 |
PEDIATRICS INTUBATION TRAY |
DYNJAA252 |
10193489297980 |
What to Do
On April 4, 2025, Medline Industries, LP, sent customers a letter recommending the following actions:
- Check inventory and stop use of affected product.
- Return the destruction form included with the letter listing the number of affected kits to be destroyed. Return this form even if there is no affected product.
- Credit will be issued after Medline Industries receives the completed form.
- Destroy all affected kits in inventory.
- Notify anyone who may have received affected products through a transfer from the organization.
- Request customers destroy affected product.
- Include customer’s destroyed product quantities on the organization’s destruction form.
Reason for Recall
Medline Industries, LP, is recalling neonatal and pediatric convenience kits that contain recalled Smiths Medical ORAL/NASAL Endotracheal Tubes. The recalled tubes may have a smaller diameter than expected, which may prevent the patient from receiving proper ventilation.
The use of these affected products may cause serious adverse health consequences, including lack of oxygen (hypoxia) that may lead to organ failure, swelling of the larynx (laryngeal edema), cardiopulmonary arrest, and death.
At this time, Medline Industries, LP, has reported eight injuries related to this issue. There have been no reports of death.
Device Use
Medline Industries, LP, neonatal and pediatric convenience kits are used for various medical procedures including intubation. The Smiths Medical ORAL/NASAL Endotracheal Tubes included in these kits help keep air flowing through a patient’s airway. They are inserted in the mouth (oral) and/or the nose (nasal) when someone needs to be intubated to maintain airway patency and support ventilation.
Contact Information
Customers in the U.S. with questions about this recall should contact 866-359-1704 or email Recalls@Medline.com.
Additional FDA Resources:
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
