Official recall record
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR14C
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-05-04
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10197344148998
- Brand on record
- Medline Industries, LP
- Product category
- Medical Device
What the authority reported
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 to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.
Record last checked against the registry on 2026-09-16.
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