FDA-Device2026-02-04Class IIPROCESSING DEFECT

Medline medical procedure kits recalled for defective MASTISOL adhesive tubing

OTHERNationwide distribution

Stop using affected Medline procedure kits

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.
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.

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-1189-2026

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