Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane Recalled by Mozarc Medical US LLC Due to Potential breach of sterile barrier packaging.

Date: April 23, 2025
Company: Mozarc Medical US LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Mozarc Medical US LLC directly.

Affected Products

Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Quantity: 95,938 units

Why Was This Recalled?

Potential breach of sterile barrier packaging.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mozarc Medical US LLC

Mozarc Medical US LLC has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report