FDA-Device2026-06-24Class IIPACKAGING DEFECT
Medline C-section convenience kits recalled for defective adhesive tubing
OTHERNationwide distribution
Medline C-section kits recalled for adhesive tubing defect
Medline convenience kits used in C-section procedures contain a recalled adhesive product with defective tubing that may crack during use, making the adhesive unusable. The affected kits were distributed nationwide. No injuries have been reported.
- Check if your facility has one of the affected kit lot numbers (26AMC363, 25KBE168, 25KMB136, 26BBO404, or 26CBN891).
- Stop using affected kits and set them aside.
- Contact Medline Industries for instructions on replacement or return.
Hazard
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Sold states
US Nationwide distribution. OUS distribution pending.
Affected count
49,654 kits total
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline convenience kits: C SECTION CDS985505G C SECTION PACK DYNJ68260D C-SECTION DYNJ905094B C-SECTION RECOVERY #2 CDS820091P
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2446-2026More Medline Industries, LP recalls
- FDA-Device2026-06-24Medline medical procedure kits recalled for catheter defects and connector detachment risk
- FDA-Device2026-06-24Medline cardiac surgery kits recalled for catheter defects
- FDA-Device2026-06-24Medline dressing change kits recalled for defective adhesive tubing
- FDA-Device2026-06-24Medline open-heart and cardiac surgery kits recalled for catheter defects
- FDA-Device2026-06-24Medline laparoscopy procedure kits recalled for catheter defects
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