Medline Industries, LP — Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126
⚠️ Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 27, 2026
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.
What's affected?
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126
- Lot code
- 21ALA586
Additional details
DYNJ21574J UDI-DI 10889942153497 Lots 21ALA586 21CLA398 21ELA408 21FLA144 21FLA788 21HLA420 21ILA431 DYNJ51126 UDI-DI 10889942122820 Lots 21ADA917
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 113,843 kits.
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