FDA recall Z-2484-2026

Medline Industries, LP · Class II · device

Product

MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR16C

Reason for recall

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.

Distribution

Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.

Key facts

Status
Ongoing
Initiation date
2026-05-04
Report date
2026-06-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2484-2026