Merit Medical Systems, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1875-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY

Product Classification:

Class II

Date Initiated: March 14, 2024

Date Posted: May 29, 2024

Recall Number: Z-1875-2024

Event ID: 94304

Reason for Recall:

Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.

Status: Ongoing

Product Quantity: 27 units

Code Information:

Lot # H2817178/ UDI: 00884450770771

Distribution Pattern:

Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated