Device recall

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

FDA recall source

Recall number

Z-0178-2027

Event id

99886

Status

Ongoing

FDA classification

Class II

Recalling firm

Medline Industries, LP

Report date

Oct 21, 2026

Posted

Oct 15, 2026

Initiated

Sep 2, 2026

Center classification date

Oct 15, 2026

Product code

OJK

Device type

Eye Tray

Reason

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.

Root cause

Under Investigation by firm

Quantity

165 kits

Code info

UDI/DI 10195327369743 (each) 40195327369744 (case). Lot Numbers: 23GBD734, 23EBQ512

Distribution

US Nationwide distribution.

Voluntary or mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States