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CLASS II · ModerateFDA

Medline Industries, LP recalls Medline surgical convenience kits labeled as: OPEN HEART

📅 Sep 2, 2026 · 📍 Nationwide
Recalling company
Medline Industries, LP
Product
Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Sep 2, 2026
Reported
Oct 21, 2026
Distribution
US Nationwide distribution.
Status
Ongoing
Quantity
165 kits
Lot / codes
UDI/DI 10195327369743 (each) 40195327369744 (case). Lot Numbers: 23GBD734, 23EBQ512
Company location
Northfield, IL
Recall type
Voluntary: Firm initiated
Recall number
Z-0178-2027
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0178-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.