FDAFDA recall Z-2788-2026 · Jul 29, 2026
Medline Industries, LP: Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES recall
Recall found
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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.
- Quantity
- 155 kits
- Distribution
- US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
- Recalling firm
- Medline Industries, LP, Northfield, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-11
Source: openFDA enforcement record Z-2788-2026 · search recall number Z-2788-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.