Medical device recalls Moderate risk

Medline Industries, LP recalls Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/…

Recall date
December 12, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1188-2026
FDA classification
Class II
Brand / firm
Medline Industries, LP
Sold / distributed
US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178, Kit SKU DYNJ65011D; 6) HEART BASIC OPEN PACK, Kit SKU DYNJ69143C; 7) SCC VEIN PACK, Kit SKU DYNJ69313; 8) CV PACK, Kit SKU DYNJ86007B.

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