Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; ...
FDA Recall #Z-1199-2026 — Class II — December 12, 2025
Product Description
Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O; 3) RR-L&D C-SECTION PACK-LF, Kit SKU DYNJ82084F.
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.
Recalling Firm
Medline Industries, LP — Northfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
96 units
Distribution
US Nationwide distribution.
Code Information
Medline Kit SKU DYNJ35494C: UDI/DI 10198459117879 (EA) 40198459117870 (CS), Lot Number 25KMD420; Medline Kit SKU DYNJ38582O: UDI/DI 10198459603709 (EA) 40198459603700 (CS), Lot Number 25KMI679; Medline Kit SKU DYNJ82084F: UDI/DI 10198459089206 (EA) 40198459089207 (CS), Lot Number 25KMD145.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated