Recall Z-1187-2026

Medline Industries, LP · initiated December 12, 2025

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP RECOVERY PACK, Kit SKU DYNJT7034;

Codes / lots: Medline Kit SKU DYNJ64837C: UDI/DI 10198459139482 (EA) 40198459139483 (CS), Lot Number 25KMJ193; Medline Kit SKU DYNJT7034: UDI/DI 10198459592591 (EA) 40198459592592 (CS), Lot Number 25KMI766;.

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.

FDA-determined 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.

Details

Recall number
Z-1187-2026
Initiated
December 12, 2025
Posted by FDA
January 28, 2026
Product code
OES – Cardiac Catheterization Kit
Quantity
1,928 total
Distribution
US Nationwide distribution.
Recalling firm
Medline Industries, LP, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1186-2026 Class IIMedline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… 12/12/2025Open, Classified
Z-1188-2026 Class IIMedline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… 12/12/2025Open, Classified
Z-1189-2026 Class IIMedline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… 12/12/2025Open, Classified
Z-1190-2026 Class IIMedline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… 12/12/2025Open, Classified
Z-1191-2026 Class IIMedline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… 12/12/2025Open, Classified
Z-1192-2026 Class IIMedline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… 12/12/2025Open, Classified
Z-1193-2026 Class IIMedline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… 12/12/2025Open, Classified
Z-1194-2026 Class IIMedline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… 12/12/2025Open, Classified
Z-1195-2026 Class IIMedline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… 12/12/2025Open, Classified
Z-1196-2026 Class IIMedline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit SKU…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… 12/12/2025Open, Classified
Z-1197-2026 Class IIMedline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… 12/12/2025Open, Classified
Z-1198-2026 Class IIMedline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit SKU…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… 12/12/2025Open, Classified
Z-1199-2026 Class IIMedline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… 12/12/2025Open, Classified
Z-1200-2026 Class IIMedline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… 12/12/2025Open, Classified