Recall
FDAHealthMay 4, 2026

Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A

⚠️ 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: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A
Lot code
23HMI132

Additional details

UDI/DI 10195327119751 (each), 40195327119752 (case), Lot Numbers: 23HMI132, 23HMA956 23GMA525, 23DMF610, 23AMH680, 22CBF155.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 384 units.

View original FDA notice →

Get Health recall alerts

Delivered to your inbox. Free. No account required.