FDA-Device2026-09-02Class IIPACKAGING DEFECT
Medline FEMORAL PACK and FEVAR kits recalled for potentially contaminated component
What this means
Medline Industries recalled two surgical convenience kits—FEMORAL PACK (SKU DYNJ909393A, Lot 25ILA297) and FEVAR (SKU DYNJ910295D, Lot 26CBT178)—because they contain a component that may be contaminated. About 71 kits were distributed across the US. No injuries have been reported.
- Check if you have either kit by matching the SKU and lot numbers listed above.
- Do not use the affected kits.
- Contact Medline Industries for instructions on return or replacement.
The agency's original wording
Hazard
Kits contain a potentially contaminated component which were recalled by the manufacturer
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
Affected count
71 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3019-2026More 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 convenience kits recalled for sharp brush edges in Healthmark channel brushes
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