medical MODERATE Updated 2026-06-24

Medline Industries, LP recalls MEDLINE Intermittent Latex Catheter Coude Pre-Connected to C

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Recalled Product

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

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI/DI 10197344149001 (each), 20197344149008 (case); ALL LOTS

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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