FDAHealthFebruary 27, 2026
Medline Industries, LP — Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC C-SECTION TRAY-LF DYNJ54603B
⚠️ 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. FTMC C-SECTION TRAY-LF DYNJ54603B
- Lot code
- 24ABO124
Additional details
DYNJ54603B UDI-DI 10195327458188 Lot 24ABO124
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 113, 843 kits.
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