Device recall
Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D
- Recall number
- Z-0168-2027
- 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
- OEQ
- Device type
- Angiography/Angioplasty Kit
- 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
- 3125 kits
- Code info
- UDI/DI 10193489461725 (each) 40193489461726 (case), Lot Numbers: 25LMF813, 25IMF341, 25HBR484, 25FBP179, 25EBJ732, 25DBK745, 25CBK191, 25BBE801, 24LBB945, 24IBT658, 24IBD265, 24GBG100, 24EBC752, 24CBQ893, 24BBJ088, 24ABE008, 23JBA374, 23HBV035, 23GBL681, 23EBK074, 23DBL164, 23DBB447, 23ABV418, 22LBG352, 22IBK243, 22HBX829, 22EBA032, 22DBO915, 22BBR573, 21LBB905, 21IBX719, 21HBG260, 21GBH209, 21DBR261, 21BBJ878.
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States