FDA Medical devices recall ·
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag… recall
- Recall number
- Z-2483-2026
- Date
- (initiated May 4, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 8260 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR14C
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 10197344148998 (each), 20197344148995 (case); ALL LOTS
Distribution
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
States: California Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2483-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.