Class IIDeviceOngoing

Medline Industries, LP

Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D

Reason for recall

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Details

Recall number: Z-0178-2027
Event ID: 99886
Recall initiated: Sep 2, 2026
Classified: Oct 15, 2026
Reported: Oct 21, 2026
Quantity: 165 kits
Distribution: US Nationwide distribution.
Initiated by: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Firm location: Northfield, IL, United States
Lot / code info: UDI/DI 10195327369743 (each) 40195327369744 (case). Lot Numbers: 23GBD734, 23EBQ512