FDA-Device2026-02-04Class IIPACKAGING DEFECT
Medline Cath Lab Pacemaker and Loop Recovery procedure kits recalled for cracked adhesive vials
What this means
Medline medical procedure kits containing MASTISOL liquid adhesive were distributed with a defect: the tubing inside the adhesive vials can crack when opened. This affects two kit types used in cardiac catheterization and loop recovery procedures. No injuries have been reported.
- Check if you have Medline Cath Lab Pacemaker Pack (SKU DYNJ64837C, Lot 25KMJ193) or Loop Recovery Pack (SKU DYNJT7034, Lot 25KMI766)
- Do not use the MASTISOL adhesive vials from these kits
- Contact Medline Industries for a replacement or refund
- If you have already used one of these kits, consult your healthcare provider
The agency's original wording
Hazard
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
1,928 total
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP RECOVERY PACK, Kit SKU DYNJT7034;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1187-2026More 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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