WhichRecall
Class IIReported 2026-02-04

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.

Recalled by Medline Industries, LP

Reason for Recall

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.

Advertisement
Recall Number
Z-1189-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-12-12
Reported
2026-02-04
Distribution
US Nationwide distribution.
Code Info
Medline Kit SKU CDS984853L: UDI/DI 10198459293535 (EA) 40198459293536 (CS), Lot Number 25KMI898; Medline Kit SKU DYNJ45641B: UDI/DI 10193489494921 (EA) 40193489494922 (CS), Lot Number 25KMH748; Medline Kit SKU DYNJT3658A: UDI/DI 10198459354007 (EA) 40198459354008 (CS), Lot Number 25KME009.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
Advertisement