FDA-Device2026-09-02Class IIPROCESSING DEFECT
Medline C-Section surgical kits recalled for potentially contaminated component
What this means
Medline Industries recalled three C-Section surgical convenience kits because they contain a potentially contaminated component from a supplier. The affected kits were distributed nationwide across 18 states. No injuries have been reported.
- Check if your facility has any of the affected Medline C-Section kits (SKU DYNJ904612L, DYNJ911755, or DYNJ912014).
- Contact Medline Industries if you have kits with the lot numbers listed in the recall notice.
- Do not use the affected kits until you confirm they are not part of this recall.
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
106 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3026-2026More 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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