FDAFDA recall Z-0168-2027 · Oct 21, 2026
Medline Industries, LP: Medline surgical convenience kits labeled as: CABG AUXILIARY PACK recall
Recall found
Product
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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.
- Quantity
- 3125 kits
- Distribution
- US Nationwide distribution.
- Recalling firm
- Medline Industries, LP, Northfield, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-02
Source: openFDA enforcement record Z-0168-2027 · search recall number Z-0168-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.