← Back to recalls

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

Class II
Recalling firm
Medline Industries, LP
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.
Affected products (lot / model / serial)
Medline Kit SKU DYNJ910103B, UDI/DI 10198459346873 (each) 40198459346874 (case), Lot Number 25FBR237; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25ABM761; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25BBD107; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBD534; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBL772.
Units affected
155 kits
Distribution pattern
US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
Firm location
Northfield, IL, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Devices
Status
Ongoing
Recall number
Z-2788-2026
Recall initiated
June 11, 2026
FDA classification date
July 23, 2026
FDA report date
July 29, 2026
FDA event ID
99329
Last updated on HTM Vibe
August 4, 2026
View on openFDA