https://gastroenterology.acponline.org/archives/2025/07/25/9.htm

Numerous infusion pumps recalled

In addition to announcing several recalls of infusion pumps, the FDA warned about the risk of heat injuries with the antinausea scopolamine transdermal system.


Several recent FDA actions are relevant to gastroenterology and hepatology.

Multiple pumps were recalled, including CADD-Solis ambulatory infusion pumps , the Novum IQ large-volume pump, certain Alaris and BD Alaris pump modules, and Z-800, Z-800F, Z-800W and Z-800WF infusion pumps by Zyno Medical.

All lots of sucralfate tablets, USP, 1 g, manufactured after June 2023 by Nostrum Laboratories, Inc., were also recalled following the company's bankruptcy and discontinuation of quality activities. No other Nostrum Labs products are affected by this recall.

A warning was added to the antinausea patch Transderm Scop (scopolamine transdermal system) as it can increase body temperature and cause heat-related complications, resulting in hospitalization or even death in some cases. Most cases occurred in children ages 17 years and younger and in adults ages 60 years and older, who may be more sensitive to body temperature control disturbances.