FDAClass IIJune 24, 2026

MEDLINE Medical Procedure Kits labeled as: CATH 22F recall

MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839

Why was MEDLINE Medical Procedure Kits labeled as: CATH 22F 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?

UDI/DI 10889942046126 (each), 40889942046127 (case), Lot Numbers: 25JMK709, 25FMJ661, 25CMG042, 24IME549, 24GMD004, 24CMF091, 24CME465, 24BMH490.

Product
MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839
Recalling firm
Medline Industries, LP
Quantity
1000 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)
Open FDA enforcement record Latest recalls