FDA-Device2026-07-29Class IIPROCESSING DEFECT
Medline pediatric and cardiac surgical kits recalled for potential Bacillus contamination
What this means
Medline Industries is recalling specific pediatric open heart and cardiac surgical convenience kits that contain BD PurPrep solution potentially contaminated with low levels of Bacillus species. The affected kits were distributed to healthcare facilities in 10 states. No injuries have been reported.
- Check your facility's inventory for the affected Medline kit SKUs (DYNJ910103B or DYNJ910961A) and lot numbers listed in this recall
- Do not use kits with lot numbers 25FBR237, 25ABM761, 25BBD107, 25FBD534, or 25FBL772
- Contact Medline Industries or your distributor for instructions on return or replacement
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
Affected count
155 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2788-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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