Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU CDS984347O; 2) HEAD AND NECK CDS-LF, Kit SKU CDS984857N; 3) NECK PACK-LF, Kit SKU DYNJ0966130K; 4) NECKLINE PACK-LF, Kit SKU DYNJ51440B; 5) THYROID PACK, Kit SKU DYNJ58742J; 6) ENT I, Kit SKU DYNJ63781B; 7) NECK PACK, Kit SKU DYNJ82751B; 8) NOSE PACK, Kit SKU DYNJ82753C; 9) WMC COCHLEAR IMPLANT ADD ON, Kit SKU DYNJ907206G.

Recall Initiated

December 12, 2025

Posted

January 28, 2026

Recall Number

Z-1190-2026

Quantity

40 units

Firm Location

Northfield, IL

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.

Distribution

US Nationwide distribution.

Lot / Code Info

Medline Kit SKU CDS984347O: UDI/DI 10198459311451 (EA) 40198459311452 (CS), Lot Number 25KMD733; Medline Kit SKU CDS984347O: UDI/DI 10198459311451 (EA) 40198459311452 (CS), Lot Number 25KMC147; Medline Kit SKU CDS984857N: UDI/DI 10198459359705 (EA) 40198459359706 (CS), Lot Number 25KMJ151; Medline Kit SKU DYNJ0966130K: UDI/DI 10198459442117 (EA) 40198459442118 (CS), Lot Number 25LMB220; Medline Kit SKU DYNJ0966130K: UDI/DI 10198459442117 (EA) 40198459442118 (CS), Lot Number 25KME804; Medline Kit SKU DYNJ51440B: UDI/DI 10198459004230 (EA) 40198459004231 (CS), Lot Number 25KMI445; Medline Kit SKU DYNJ58742J: UDI/DI 10198459254710 (EA) 40198459254711 (CS), Lot Number 25KMC534; Medline Kit SKU DYNJ63781B: UDI/DI 10198459549595 (EA) 40198459549596 (CS), Lot Number 25KMB410; Medline Kit SKU DYNJ82751B: UDI/DI 10198459039157 (EA) 40198459039158 (CS), Lot Number 25LMB068; Medline Kit SKU DYNJ82751B: UDI/DI 10198459039157 (EA) 40198459039158 (CS), Lot Number 25KMI309; Medline Kit SKU DYNJ82753C: UDI/DI 10198459446887 (EA) 40198459446888 (CS), Lot Number 25KMC126; Medline Kit SKU DYNJ907206G: UDI/DI 10198459368028 (EA) 40198459368029 (CS), Lot Number 25KBL336.

Root Cause

Nonconforming Material/Component

Action Taken

Medline Industries issued a URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/12/2025 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-25-251-FGX2 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product." For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.