Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Prelude Guide Sheath Roadster Recalled by Merit Medical Systems, Inc. Due to Their is a potential that sheaths labeled with...
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 Merit Medical Systems, Inc. directly.
Affected Products
Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
Quantity: 27 units
Why Was This Recalled?
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Merit Medical Systems, Inc.
Merit Medical Systems, Inc. has 135 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report