Recall Z-2788-2026— Medline Industries, LP

Name: FDA recall Z-2788-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-11

Class II · Ongoing

Class II FDA medical device recall by Medline Industries, LP, initiated 2026-06-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.. Reason: Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species..

Recalling firm: Medline Industries, LP
Classification: Class II
Status: Ongoing
Initiated: 2026-06-11
Firm location: Northfield, IL, United States

Product description

Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.

Reason for recall

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

Data sourced from openFDA. This site is unofficial and independent of the FDA.