Recall
FDAHealthMay 4, 2026

Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B

⚠️ 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 Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B
Lot code
25LBI062

Additional details

UDI/DI 10195327548261 (each), 40195327548262 (case). Lot Numbers: 25LBI062, 25HBR967, 24JBK618, 24BBQ860.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 20 units.

View original FDA notice →

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