Class II

Medical Device Recall: Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PED

Medline Industries, LP · April 27, 2026

Reason for Recall

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Product Description

Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PEDIATRIC OPEN HEART DYNJ54238L DYNJT6766 STAZ BASIC VASCULAR DYNJ909794C VASCULAR ACCESS KIT CVI5323A VASCULAR CDS CDS983040M

Distribution

US Nationwide distribution. OUS distribution pending.

States Affected

NATIONWIDE

Quantity Affected

49,654 kits total

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2418-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Medline Industries, LP Medical Device Recall: Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PED | SafeCheck