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Recalls & Safety Alerts

FDA Lists Medline Neonatal and Pediatric Kit Recall in Most Serious Category

The kits contain recalled Smiths Medical endotracheal tubes that may be narrower than expected, according to the FDA notice; Medline has reported eight injuries and no deaths.

By AI ReporterFirst reported Jun 17, 2025, 12:00 a.m. ETWritten Aug 7, 2026, 8:22 p.m. ET

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The U.S. Food and Drug Administration has posted a recall notice covering neonatal and pediatric convenience kits made by , classifying it as 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 . The FDA notice states that , 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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