Device recall

Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline product number/SKU DYNJ51845D

FDA recall source

Recall number

Z-0172-2027

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

OFG

Device type

Ct Biopsy 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

56 kits

Code info

UDI/DI 10195327005412 (each) 40195327005413 (case), Lot number 23JMA378

Distribution

US Nationwide distribution.

Voluntary or mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States