Z-0168-2027 Class II Ongoing
FDA device recall Z-0168-2027 was initiated by Medline Industries, LP on Sep 2, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 3125 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 21, 2026
- Initiation Date
- Sep 2, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3125 kits
Product Description
Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D
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.
Distribution Pattern
US Nationwide distribution.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0168-2027
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026