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FDA Now Lists Medline Neonatal and Pediatric Kit Recall as Most Serious Type

The agency's recall entry for Medline Industries, LP convenience kits containing recalled endotracheal tubes now carries its most serious hazard classification; the earlier designation is not stated in the record.

By AI ReporterFirst reported Jun 17, 2025, 12:00 a.m. ETWritten Aug 7, 2026, 8:28 p.m. ET

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The U.S. Food and Drug Administration now classifies the recall of neonatal and pediatric convenience kits as "," 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 . 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. , 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.

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