Recall Z-2788-2026 ยท OEZ Cardiovascular Procedure Kit
Medline Industries, LP
Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.
| Date | Jul 23, 2026 (initiated Jun 11, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Process change control |
| Action | Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees via email and USPS first class mail. The notice explained the issue with the device, potential harms, and requested the following: REQUIRED ACTION: 1. Immediately check stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete the response form. Please list the quantity of affected product in inventory on the form. Even if there is no affected product in inventory, plea |
| Quantity | 155 kits |
| Distribution | US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.