FDA recall Z-2788-2026

Medline Industries, LP · Class II · device

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 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.

Distribution

US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.

Key facts

Status
Ongoing
Initiation date
2026-06-11
Report date
2026-07-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2788-2026