FDA-Device2026-09-02Class IIPACKAGING DEFECT
Medline surgical procedure kits recalled for potentially contaminated component
What this means
Medline Industries is recalling four types of surgical convenience kits because they contain a potentially contaminated component supplied by a manufacturer. The recalled kits were distributed nationwide to medical facilities. No injuries have been reported.
- If your facility received one of the affected kits, stop using it immediately.
- Check the kit SKU and lot number against the recall details to confirm if you have an affected kit.
- 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
94 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit SKU DYNJ903479L; 4) LAPAROSCOPY, Medline Kit SKU DYNJ903479M.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3022-2026More 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 surgical convenience kits recalled for elevated endotoxin levels in neurological sponges
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