Medline Industries, LP — MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 4, 2026
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
What's affected?
- Product
- MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.
- Lot code
- S
Additional details
1. DYNC1816, UDI/DI 10080196990627 (each), 40080196990628 (case); 2. DYND10350, UDI/DI 10080196028665 (each), 40080196028666 (case). ALL LOTS
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 8327756 units.
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