FDA-Device2026-06-24Class IIPACKAGING DEFECT
Medline convenience kits recalled for defective adhesive tubing that may crack during use
What this means
Medline convenience kits containing a recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive have been distributed nationwide. The butyrate tubing in these kits may crack when the adhesive is dispensed, making the product unusable.
- Check if you have a Medline breast-hernia-port convenience kit with lot number 26AME511 or 26AMG737.
- Do not use the kit if you have one of these lots.
- Contact Medline Industries for instructions on how to return or replace the affected kit.
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: BREAST-HERNIA-PORT CDS-LF CDS984853L
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2420-2026More 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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