FDA-Device2026-07-01Class IIPROCESSING DEFECT
Medline Major Basin Set convenience kits recalled for unapproved syringe design changes
Medline convenience kits recalled for unapproved design changes
Medline Industries identified that certain 10mL polycarbonate colored syringes included in Major Basin Set convenience kits (model DYNJ85723) were modified in ways that were not approved by the FDA. These design changes were made outside of the FDA clearance process. Approximately 113,843 kits containing these syringes have been distributed nationwide.
- Check if you have a Medline Major Basin Set convenience kit (model DYNJ85723, Lot 24ABO130).
- If you have this kit, contact Medline Industries or your supplier for instructions on return or replacement.
- Do not use the syringes from affected kits until you receive guidance from Medline.
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.
Who it affects
All ages
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. MAJOR BASIN SET DYNJ85723
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2588-2026More Medline recalls
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