FDA-Device2026-06-24Class IIPACKAGING DEFECT
Medline convenience kits recalled for defective adhesive tubing
What this means
Medline convenience kits (Basic Eye and Tubal Ligation models) contain a recalled adhesive product from Ferndale Laboratories. The tubing in the adhesive applicator may crack when used, making the kit unusable.
- Check if you have a Medline Basic Eye (DYNJ905154I) or Tubal Ligation CDS (CDS760053K) kit.
- If you have one of these kits, contact Medline or your healthcare provider for instructions.
- Do not use the kit if the tubing appears cracked or damaged.
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: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CDS760053K
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2435-2026More 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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