Merit Medical Systems, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1485-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").

Product Classification:

Class II

Date Initiated: April 14, 2014

Date Posted: April 30, 2014

Recall Number: Z-1485-2014

Event ID: 68041

Reason for Recall:

Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft. This lot was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA35260EX, which has an angled tip, standard shaft and Chinese unit labeling.

Status: Terminated

Product Quantity: 173

Code Information:

Lot No. K556399, Expires 2016-10

Distribution Pattern:

Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees.

Voluntary or Mandated:

Voluntary: Firm initiated