FDA-Device2026-06-24Class IIPACKAGING DEFECT
Medline convenience kits recalled for defective adhesive tubing that may crack during use
OTHERNationwide distribution
Medline convenience kits recalled for cracked adhesive tubing
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.
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: BREAST-HERNIA-PORT CDS-LF CDS984853L
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2420-2026More 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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