Merit Medical Recalls Hydrophilic Guide Wires Due to Labeling Discrepancy
Merit Medical Systems is voluntarily recalling specific lots of Laureate Hydrophilic Guide Wires due to a discrepancy between carton and unit labeling.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling discrepancy and lot mixing without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Merit Medical Systems, Inc. is voluntarily conducting a recall of Merit Laureate Hydrophilic Guide Wires. The recall addresses a discrepancy between the carton and unit labeling for specific catalog numbers and lot numbers.
The source text identifies Lot No. K556399 (173 units) of catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft, as being partially mixed with another lot. The structured product information also lists Lot No. K556402 of catalog number LWSTDA35260EX, which has an angled tip and a standard shaft, with a quantity of 186 units. The distribution pattern is listed as worldwide, specifically USA Nationwide and China.
No illnesses or injuries are reported in the source text. The recall is driven by the labeling discrepancy and lot mixing. Consumers and healthcare providers should stop using the affected devices and contact Merit Medical Systems for further instructions.
The recalled product
- Product
- Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- Affected units
- 186
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot No. K556402
- Expires 2016-10
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Merit Medical Systems, Inc.
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- HighSplashwire hydrophilic guide wire pouches have unsealed portions
FDA (Devices) · 2026-06-24
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateMerit Medical Systems Recalls Vein Kits Due to Incorrect Latex Labeling
FDA (Devices) · 2019-10-09
- HighSplashwire hydrophilic guide wire pouches have unsealed portions
FDA (Devices) · 2026-06-24
- ModerateMerit Medical Systems Recalls Custom Procedure Kits Due to Latex Labeling Error
FDA (Devices) · 2019-10-09
- HighMerit Medical Guide Sheath Roadster Recalled for Incorrect Dilator Sizing
FDA (Devices) · 2024-05-29
- HighMerit Medical Prelude Introducer Sheath Recalled for Incorrect Dilator
FDA (Devices) · 2021-08-18
- ModerateMerit Medical Recalls Inflation Syringe Kits Due to Labeling Errors
FDA (Devices) · 2016-10-12