The FDA announced on Feb. 27, 2026, that Medline Industries, LP is recalling Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes due to unapproved design changes outside of FDA clearance.
How to tell if you have it
- Brand: Medline
- Product: Convenience kits containing 10mL Polycarbonate Colored Syringes
- SKUs/Lots: CATARACT FULL BODY DYNJ85743 (Lots 24ABP082, 24BBA479); VASCULAR PACK DYNJ81610C (Lot 24BBB405); MINIMALLY INVASIVE PACK-LF DYNJ0843063L (Lots 23LDB992, 24BDA641, 24BDA782, 24FDA795, 24GDB014, 24HDB074); PEDIATRIC CATH ANGIO PACK DYNJ54755J (Lots 24ABJ741, 24CBI600, 24EBA488, 24FBM084, 24GBN355, 24HBH571); PERIPHERAL ARTERIOGRAM RAD DYNJ61383C (Lot 24CLA801); POSTERIOR SPINE PACK-LF DYNJ0843339O (Lots 24CDB480, 24DDA248, 24GDB068); UPPER EXTREMITY DYNJ61907A (Lot 24ABP069); VISCERAL ANGIOGRAM PACK-LF DYNJ0429121L (Lot 24BMH315)
- Quantity: 113,843 kits
- Distribution: US Nationwide including 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 Barbados
The hazard
The firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. The products were not initially reported in RES 98601.
Context
GovInfoNow's records show Medline Industries, LP has 68 other recalls on record since July 31, 2025. Other recent recalls of similar products include Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories recall (Aug. 14, 2026), Medline Convenience Kits Recall for fungal contamination risk (Aug. 11, 2026), and Medline Sinus Packs with Sharp Brush Edges Recalled for Cut Risk (Aug. 10, 2026). Other recent recalls of similar products include B Braun Spinocan Spinal Needle Kits Recall for potential quality issues (May 6, 2026), Windstone Aligned Medical AMS16835 Fluids Kit Recall for quality issues (April 27, 2026), and Braun Medical Spinal Needle Kits Recall for potential quality issues with Bupivacaine (May 6, 2026).