FDA-Device2026-09-02Class IIPACKAGING DEFECT
Medline surgical convenience kits recalled for potentially contaminated component
What this means
Medline Industries is recalling five surgical convenience kits because they contain a component that may be contaminated. The affected kits were distributed nationwide to hospitals and surgical centers in 18 states.
- Check if your facility has any of the five affected kit types or lot numbers listed in this recall
- Quarantine affected kits and do not use them
- Contact Medline Industries for instructions on return or disposal
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
169 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L; 3) GYN LAP HYSTERECTOMY CDS, Medline Kit SKU CDS982662Q; 4) CMH VAG HYSTERECTOMY PK-LF, Medline Kit SKU DYNJ54382F; 5) A P RESECTION, Medline Kit SKU DYNJ903467L.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3027-2026More 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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