Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68041

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 14, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Merit Medical Systems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-1485-2014
Recall number
Z-1485-2014
Initiated
April 14, 2014
Classification
Class II
Status
Terminated
Quantity
173

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No. K556399, Expires 2016-10

Distribution pattern

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

device · product 2 of 2

Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").

Z-1486-2014
Recall number
Z-1486-2014
Initiated
April 14, 2014
Classification
Class II
Status
Terminated
Quantity
186

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, lot number K556399 (173 units), which has a straight tip and a stiff shaft. Lot K556399 was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA3

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, lot number K556399 (173 units), which has a straight tip and a stiff shaft. Lot K556399 was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA3

Code information

Lot No. K556402, Expires 2016-10

Distribution pattern

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