FDA-Device2026-02-04Class IIPROCESSING DEFECT
Medline medical procedure kits recalled for defective MASTISOL adhesive tubing
What this means
Medline distributed three medical procedure convenience kits containing MASTISOL liquid adhesive with a defect: the tubing can crack when the adhesive vial is opened. This affects breast-hernia-port, breast biopsy, and dermatology procedure kits. No injuries have been reported.
- Check if you have one of the affected kits by SKU number: CDS984853L, DYNJ45641B, or DYNJT3658A.
- Do not use the MASTISOL adhesive from these kits if the tubing is cracked or leaking.
- Contact Medline or your hospital procurement department for replacement kits or adhesive.
- Report any problems with the product to Medline or the FDA.
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) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST BIOPSY PACK, Kit SKU DYNJ45641B; 3) DERMATOLOGY PACK, Kit SKU DYNJT3658A.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1189-2026More 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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