FDA-Device2026-07-01Class IIPROCESSING DEFECT
Medline convenience kits with syringes recalled for unapproved design changes
What this means
Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The affected kits include Dr G's Breast Pack, Lipo Supplement Pack-LF, and Plastic Pack products distributed nationwide.
- Check your kit against the lot numbers: 24ABS353, 24BBB383, 24BBD114, or 24ABP053.
- Stop using affected kits and contact Medline Industries for instructions on return or replacement.
- If you have questions, contact Medline customer service with your kit SKU or UDI-DI number.
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. DR G'S BREAST PACK DYNJ51124B LIPO SUPPLEMENT PACK-LF DYNJ0341174D PLASTIC PACK DYNJ66746 DYNJ85702
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2584-2026More 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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