Medline Neonatal and Pediatric Kit Recall Expanded to 10 Product Codes
The FDA's recall listing for Medline Industries, LP convenience kits containing recalled Smiths Medical endotracheal tubes now covers ten identifying codes, in a recall the agency classifies as the most serious type.
4 reports on this incident · first at Aug 7, 2026, 8:22 p.m. ET
Earlier reports
Aug 7, 2026, 8:28 p.m. ET
FDA Now Lists Medline Neonatal and Pediatric Kit Recall as Most Serious Type
The U.S. Food and Drug Administration now classifies the recall of Medline Industries, LP neonatal and pediatric convenience kits as "the most serious type," according to the agency's medical device recall entry. The entry does not state what the classification was before the change, and the FDA's own terms for the earlier designation are not on the record.
In the FDA's terms, the classification reflects the hazard the agency associates with the affected product. The recall entry describes that hazard as a lack of oxygen (hypoxia) that may lead to organ failure, swelling of the larynx (laryngeal edema), cardiopulmonary arrest, and death.
The kits, which the FDA says are used for various medical procedures including intubation, were recalled because they contain recalled Smiths Medical ORAL/NASAL Endotracheal Tubes that may have a smaller diameter than expected, which may prevent the patient from receiving proper ventilation, according to the agency. The recall was initiated on April 4, 2025.
Medline Industries, LP, has reported eight injuries related to this issue, according to the FDA entry, which states there have been no reports of death. The remedy listed by the agency directs customers to check inventory and stop use of the affected product, return the destruction form included with the letter listing the number of affected kits to be destroyed, and destroy all affected kits in inventory.
The FDA entry lists the identifying codes for the affected kits as ACC010371C 10193489268188, ACC010381A 10193489800944, ACC010381B 10193489457803, ACC010381C 10193489922127, ACC010395 10193489218152, ACC010397 10193489218169, ACC010541A 10195327036980, ACC010541B 10195327153649, ACC010541C 10198459155765, and DYNJAA252 10193489297980.
Aug 7, 2026, 8:26 p.m. ET
Medline Reports Eight Injuries Linked to Recalled Neonatal and Pediatric Intubation Kits
Medline Industries, LP, has reported eight injuries related to a recall of its neonatal and pediatric convenience kits, according to the U.S. Food and Drug Administration. The FDA states there have been no reports of death.
The agency's notice says the kits, used for various medical procedures including intubation, contain recalled Smiths Medical ORAL/NASAL Endotracheal Tubes that may have a smaller diameter than expected, which may prevent the patient from receiving proper ventilation. The FDA lists the hazard as a lack of oxygen (hypoxia) that may lead to organ failure, swelling of the larynx (laryngeal edema), cardiopulmonary arrest, and death.
The FDA has classified the recall as the most serious type. The recall was initiated on April 4, 2025.
The agency instructs users to check inventory and stop use of the affected product, return the destruction form included with the recall letter listing the number of affected kits to be destroyed, and destroy all affected kits in inventory. Affected product codes listed by the FDA include ACC010371C 10193489268188, ACC010381A 10193489800944, ACC010381B 10193489457803, ACC010381C 10193489922127, ACC010395 10193489218152, ACC010397 10193489218169, ACC010541A 10195327036980, ACC010541B 10195327153649, ACC010541C 10198459155765 and DYNJAA252 10193489297980.
Aug 7, 2026, 8:22 p.m. ETFirst report
FDA Lists Medline Neonatal and Pediatric Kit Recall in Most Serious Category
The U.S. Food and Drug Administration has posted a recall notice covering neonatal and pediatric convenience kits made by Medline Industries, LP, classifying it as the most serious type of recall. The FDA notice lists the recall as initiated on April 4, 2025. The matter is still developing.
According to the FDA, the kits are used for various medical procedures including intubation, and the recall was prompted because they contain recalled Smiths Medical ORAL/NASAL Endotracheal Tubes that may have a smaller diameter than expected, which may prevent the patient from receiving proper ventilation. The agency describes the hazard as a lack of oxygen (hypoxia) that may lead to organ failure, swelling of the larynx (laryngeal edema), cardiopulmonary arrest, and death.
The FDA notice states that Medline Industries, LP, has reported eight injuries related to this issue, and that there have been no reports of death.
The remedy set out in the notice instructs customers to check inventory and stop use of the affected product, return the destruction form included with the letter listing the number of affected kits to be destroyed, and destroy all affected kits in inventory. The identifying codes listed in the notice are ACC010371C 10193489268188, ACC010381A 10193489800944, ACC010381B 10193489457803, ACC010381C 10193489922127, ACC010395 10193489218152, ACC010397 10193489218169, ACC010541A 10195327036980, ACC010541B 10195327153649, ACC010541C 10198459155765 and DYNJAA252 10193489297980.
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