Z-2742-2018Class II

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

Name: Z-2742-2018 1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body
Creator: Merit Medical Systems, Inc.
Published: 2018-02-02
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2018-02-02 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of 1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body on 2018-02-02. FDA classified it as Class II and gives the reason as "Supplier manufacturing defect with the syringe plunger tip". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2742-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-02
Posted: 2018-08-10
Terminated: 2020-11-30
Recalling firm: Merit Medical Systems, Inc.
Product: 1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
Product code: FMF Syringe, Piston
Reason for recall: Supplier manufacturing defect with the syringe plunger tip.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On February 2, 2018 Merit Medical sent a "URGENT PRODUCT RECALL NOTICE" letter to all their consignees requesting the following actions; Actions required of you: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. Please fill out, scan and email the completed CRF to Merit Customer Service at [email protected] or fax at 801.316.4880 within 10 days. 5. Please immediately return all affected lots in your possession to Merit, per the instructions found in the CRF. If you have any questions concerning this communication, please dont hesitate to contact your Merit Sales Representative or Merit Customer Service at 801.208.4381.
Quantity in commerce: 22,234
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2742-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2742-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-10

Product code FMF

K173601Class IIMerit SyringeMerit Medical Systems, Inc. / cleared 2018-01-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)