FDA-Device2026-06-24Class IIPROCESSING DEFECT
Medline surgical convenience kits recalled for defective adhesive tubing
What this means
Multiple Medline surgical convenience kits contain a recalled batch of Ferndale Laboratories MASTISOL Liquid Adhesive with defective tubing. The butyrate tubing may crack when used, making the adhesive unusable during surgical procedures.
- Check your Medline convenience kit against the specific lot numbers listed in the recall notice.
- Do not use affected kits in surgical procedures.
- Contact Medline or your supplier for replacement or instructions on returning the affected kits.
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: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PEDIATRIC OPEN HEART DYNJ54238L DYNJT6766 STAZ BASIC VASCULAR DYNJ909794C VASCULAR ACCESS KIT CVI5323A VASCULAR CDS CDS983040M
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2418-2026More 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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