Recall Z-2592-2026 ยท OES Cardiac Catheterization Kit
Medline Industries, LP
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRAM DYNJ28082D DYNJ28082F CARDIAC CATH DYNJ67349 CARDIAC CATH PACK DYNJ57874C CATH I PLUS-LF DYNJSCL100 CATH III PLUS-LF DYNJSCL300 CATH LAB ANGIOGRAPHY PACK DYNJ50779F CATH LAB
| Date | Jun 25, 2026 (initiated Feb 27, 2026) |
| Status | Open, Classified |
| Reason | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. |
| Root cause | No Marketing Application |
| Action | This entry catalogues SKUs communicated through the same letter documented in RES 98601 which were inadvertently missed in the initial report to the FDA. Firm began notifying customers on February 27, 2026 via letters titled "URGENT MEDICAL DEVICE RECALL". Customers were instructed to immediately check stock for affected product and quarantine any affected units. Upon receipt of the customers' response form reporting the quantity of affected product on hand, the firm will provide over-labels to place on affected inventory. Labels contain instructions for staff to remove and discard the affe |
| Quantity | 113, 843 kits |
| Distribution | US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.