Medline Industries, Lp: Cardiovascular Procedure Kit
Recall Summary Medline Industries is recalling two cardiovascular procedure kits (Pediatric Open Heart Moses and Basic Heart CDS) that contain BD PurPrep solution which may be contaminated with low levels of Bacillus bacteria. The kits were distributed to hospitals and medical facilities in ten states: Connecticut, Florida, Kansas, Maryland, Massachusetts, Montana, New York, Ohio, Oregon, and Virginia. This is a Class II recall, meaning the contamination could cause serious health consequences if the kits are used.
- Recalling firm
- Medline Industries, LP
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-11
- Status
- Open, Classified
- Areas affected
- CT, FL, KS, MD, MA, MT, NY, OH, OR, VA
- Distribution
- US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/39e7eecd-bd0b-4a46-a926-b0cfcffef7c7