The FDA has posted 11 enforcement recalls of piston syringe devices since 2025, including 5 Class I (most serious) recalls. Most recent report: Jul 8, 2026.
A single lot of expired syringes were distributed due to a distribution system control failure.
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…
The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Lack of sterility assurance.
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause…
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause…
Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder;…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Syringe, Piston”). Informational only — verify against the FDA before acting.