CLASS II Device recall · Reported 22 Aug 2018 · FDA Enforcement Report

Medallion Syringes Are used to inject fluids into recalled

Merit Medical Systems is recalling Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body, distributed nationwide in the US. The recall was initiated on 2 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog 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.

Quantity recalled22,234

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2742-2018
FDA event ID: 80650
Recalling firm: Merit Medical Systems, South Jordan, UT
Classification: Class II
Status: Terminated
Recall initiated: 2 Feb 2018
FDA classified: 10 Aug 2018
Reported: 22 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Syringes & Needles

Timeline

2 Feb 2018	Recall initiated by company
10 Aug 2018	Classified by FDA	+189 days
22 Aug 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Supplier manufacturing defect with the syringe plunger tip.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.

Where it was distributed

Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MD, ME, MI, MN, MO, NC, ND, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TB, TN, TX, UT, VA, WI, and WV; and countries of; Canada, Colombia, France, and Italy.

Nationwide Alabama Arkansas Arizona California Colorado Florida Georgia Illinois Indiana Kansas Louisiana Maryland Maine Michigan Minnesota Missouri North Carolina North Dakota New Jersey New Mexico

Questions about this recall

Why was it recalled?

Supplier manufacturing defect with the syringe plunger tip.

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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