The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2742-2018·Announced 2018-08-22

Merit Medical Systems Recalls 1mL Medallion Syringes Due to Plunger Defect

Merit Medical Systems is recalling 22,234 units of 1mL Medallion Syringes due to a manufacturing defect in the plunger tip.

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, which typically involves a temporary or medically reversible adverse health consequence. The source text does not report any injuries, illnesses, or deaths, and the defect is a manufacturing issue with the plunger tip rather than a high-risk pathogen or structural failure leading to immediate severe harm.

Plain-English summary

Merit Medical Systems, Inc. is recalling 22,234 units of 1mL Medallion Syringes. These syringes are used to inject fluids into, or withdraw fluids from, the body. The recall is due to a supplier manufacturing defect with the syringe plunger tip.

The affected products were distributed nationwide in the United States to specific states and internationally to Canada, Colombia, France, and Italy. The recall covers specific catalog and lot numbers, including K01-05526P, K01-07427, and MSS011-DG, among others.

Consumers and healthcare facilities should check their inventory for the specific catalog and lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to Merit Medical Systems or the distributor.

The recalled product

Product
1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Syringes
Hazard
Affected units
22,234

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 (17)

  • Catalog Number: Lot Number: K01-05526P H1258821
  • K01-07427 H1263015
  • K01-07477P H1250809 and H1242962
  • K01-07930P H1246733
  • MSS011-DG H1246809
  • K02-00565C H1258361
  • MSS011-LG H1246810
  • K02-01260B H1258575 and H1265248
  • MSS011-PR H1242752
  • MSS011-R H1242754 and H1255507
  • K02-01331A H1252652
  • K04-00748 H1258488 and H1264381
  • MSS011-Y H1246811
  • MSS011-YP H1242927
  • K12-03636 H1258530
  • and MSS011 H1242750
  • H1246807 and H1255504.

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

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