FDA-Device2026-07-01Class IIPROCESSING DEFECT
Medline surgical convenience kits recalled for unapproved syringe design changes
What this means
Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were modified with design changes that were not approved by the FDA. These kits are used in surgical and medical procedures including cataract surgery, vascular interventions, and spine procedures.
- Check if your facility uses any of the affected kit model numbers (DYNJ85743, DYNJ81610C, DYNJ0843063L, DYNJ54755J, DYNJ61383C, DYNJ0843339O, DYNJ61907A, or DYNJ0429121L)
- Review the lot numbers on your inventory against the FDA recall notice
- Contact Medline Industries or your medical device supplier for instructions on return or replacement
The agency's original wording
Hazard
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
113,843 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C POSTERIOR SPINE PACK-LF DYNJ0843339O UPPER EXTREMITY DYNJ61907A VISCERAL ANGIOGRAM PACK-LF DYNJ0429121L
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2590-2026More Medline recalls
- FDA-Device2026-09-30Medline neurological surgical kits recalled for elevated endotoxin levels in sponges
- FDA-Device2026-09-30Medline Convenience Kits Major Pack recalled for elevated endotoxin levels in neurological sponges
- FDA-Device2026-09-30Medline Convenience Kits recalled for elevated endotoxin levels in sponges
- FDA-Device2026-09-30Medline sinus convenience kits recalled for sharp brush edges risking cut injury
- FDA-Device2026-09-30Medline surgical convenience kits recalled for elevated endotoxin levels in neurological sponges
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