MEDLINE Urethral Catheter recall
MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16 Fr; 7. DYND13518 - 18 Fr; 8. DYND13520 - 20 Fr; 9. DYND13522 - 22 Fr; 10. DYND13614 - 14 Fr; 11. DYND13616 - 16 Fr.
Why was MEDLINE Urethral Catheter recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1. DYND13508, UDI/DI 10080196031139 (each), 20080196031136 (case); 2. DYND13510, UDI/DI 10080196726462 (each), 40080196726463 (case); 3. DYND13512, UDI/DI 10080196031177 (each), 40080196031178 (case); 4. DYND13514, UDI/DI 10080196726219 (each), 40080196726210 (case); 5. DYND13515, UDI/DI 10080196031214 (each), 40080196031215 (case); 6. DYND13516, UDI/DI 10080196031221 (each), 40080196031222 (case); 7. DYND13518, UDI/DI 10080196031245 (each), 40080196031246 (case); 8. DYND13520, UDI/DI 10080196031252 (each), 40080196031253 (case); 9. DYND13522, UDI/DI 10080196061259 (each), 40080196061250 (case); 10. DYND13614, UDI/DI 10080196031276 (each), 30080196031270 (case); 11. DYND13616, UDI/DI 10888277720879 (each), 20888277720876 (case); ALL LOTS
- Product
- MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16 Fr; 7. DYND13518 - 18 Fr; 8. DYND13520 - 20 Fr; 9. DYND13522 - 22 Fr; 10. DYND13614 - 14 Fr; 11. DYND13616 - 16 Fr.
- Recalling firm
- Medline Industries, LP
- Quantity
- 2237471 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
- Recall date
- June 24, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)