Z-2484-2026 Class II Ongoing
FDA device recall Z-2484-2026 was initiated by Medline Industries, LP on May 4, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 10980 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 24, 2026
- Initiation Date
- May 4, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10980 units
Product Description
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 Pattern
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Code Information
UDI/DI 10197344149001 (each), 20197344149008 (case); ALL LOTS
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2484-2026
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026