FDA-Device2026-07-01Class IIPROCESSING DEFECT
Medline C-Section Tray convenience kits recalled for unapproved syringe design changes
What this means
Medline Industries identified unapproved design changes to 10mL syringes in certain C-Section Tray convenience kits that were not cleared by the FDA under the original product authorization. The affected kits were distributed nationwide and to Barbados.
- Check your inventory for Medline FTMC C-SECTION TRAY-LF kits with model DYNJ54603B (UDI-DI 10195327458188), particularly Lot 24ABO124.
- Contact Medline directly for instructions on returning or replacing affected kits.
- Do not use affected kits until you receive guidance from Medline or your healthcare facility.
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. FTMC C-SECTION TRAY-LF DYNJ54603B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2596-2026More 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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