TemporaryFDAOngoing
Can cause harm that is usually temporary.
Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D
Check the device or its packaging for
UDI/DI 10195327369743 (each) 40195327369744 (case). Lot Numbers: 23GBD734, 23EBQ512
- Why
- 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.
- Distributed
- US Nationwide distribution.
- Company
- Medline Industries, LP
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0178-2027 · retrieved 15 October 2026
Read the official notice