Class II
Medical Device Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A
Medline Industries, LP · February 27, 2026
Reason for Recall
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Distribution
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.
States Affected
NATIONWIDE
Quantity Affected
113, 843 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2595-2026
Status: ongoing
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