FDA-Device2026-06-24Class IIPROCESSING DEFECT
Medline dressing change kits recalled for defective adhesive tubing
What this means
Several Medline convenience kits used for central line, PICC, dialysis, and port access dressing changes contain a recalled batch of Ferndale Laboratories MASTISOL Liquid Adhesive. The tubing in these adhesive bottles may crack when used, making the product unusable.
- Check if you have one of the affected Medline kits (EBSI1705A, EBSI1057A, EBSI1498, EBSI1585, EBSI1621, or EBSI1837).
- Do not use kits with the affected lot numbers listed in the recall.
- Contact your supplier or Medline for a replacement 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: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING CHANGE EBSI1498 EBSI CVC DRESSING CHANGE KIT EBSI1585 PICC DRESSING CHANGE TRAY EBSI1621 PORT ACCESS KIT EBSI1837
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2438-2026More 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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