FDAHealthFebruary 27, 2026
Medline Industries, LP — Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551
⚠️ 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. KIT NEURO CSTM SAMP0551
- Lot code
- 22JBG593
Additional details
SAMP0551 UDI-DI 10195327268503 Lots 22JBG593 22JBJ361
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 113,843 kits.
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