The FDA has posted 5 enforcement recalls of chest drainage kit devices since 2025, including 1 Class I (most serious) recall. Most recent report: Jun 24, 2026.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if ster…
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles;…
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles;…
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Chest Drainage Kit”). Informational only — verify against the FDA before acting.