FDA-Device2026-06-24Class IIPACKAGING DEFECT
Medline C-section convenience kits recalled for defective adhesive tubing
What this means
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.
The agency's original wording
Hazard
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Intended for
Adults
Illnesses reported
None reported
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 recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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