Z-2482-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2026
- Initiation Date
- May 4, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 235658 units
Product Description
MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350
Reason for Recall
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Code Information
UDI/DI 10080196996759 (each), 40080196996750 (case); ALL LOTS