Class II

Medical Device Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126

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-2581-2026

Status: ongoing

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