FDA-Device2026-09-02Class IIPACKAGING DEFECT
Medline surgical convenience kits recalled for potentially contaminated component
What this means
Medline Industries recalled four surgical convenience kits because they contain a component that may be contaminated. The affected kits are used in minor lithotomy, major lithotomy, gynecological laparotomy, and universal gynecological procedures. A total of 419 kits were distributed nationwide.
- Check if your facility has any of the affected kits by matching the SKU and lot numbers listed in the recall notice.
- Do not use affected kits. Contact Medline Industries or the FDA if you have questions about your specific lot numbers.
- Report any adverse events or injuries related to these kits to the FDA's MedWatch program.
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
419 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3028-2026More 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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