FDA-Device2026-07-01Class IIMISBRANDING
Medline convenience kits with 10mL syringes recalled for unapproved design changes
What this means
Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were modified in ways that were not approved by the FDA. These design changes were not part of the original FDA clearance for these products. The kits are used in medical settings for procedures like central line insertion, vascular access, and fistula management.
- Check if your facility has any of the affected kits (DYNJ41089, DYNJ62827A, DYNJ47899A, DYNJ44123B, DYNJ68037A, DYNJ0101291F) and the lot numbers listed in the recall.
- Do not use affected kits until you receive updated guidance from Medline or your healthcare facility.
- Contact Medline Industries or your facility's medical device coordinator if you have questions about which products are affected.
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. CENTRAL LINE TRAY DYNJ41089 FISTULAGRAM PACK DYNJ62827A FISTULOGRAM PACK DYNJ47899A INVASIVE LINE INSERTION DYNJ44123B NON VASCULAR PACK DYNJ68037A VASCULAR ACCESS PACK-LF DYNJ0101291F
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2594-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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