FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: 1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
- Recall number
- Z-2742-2018
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- 1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
- Status
- Terminated
- Initiated
- 2018-02-02
- Posted
- not on file
- Terminated
- 2020-11-30
- Reason
- Supplier manufacturing defect with the syringe plunger tip.
- 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 response@merit.com 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K173601"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28