Z-1889-2017Class II

1 mL Medallion Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB...

Name: Z-1889-2017 1 mL Medallion Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB...
Creator: Merit Medical Systems, Inc.
Published: 2017-03-23
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2017-03-23 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of 1 mL Medallion Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG... on 2017-03-23. FDA classified it as Class II and gives the reason as "Merit Medical Systems announces a voluntary field action for the 1mL Medallion Syringes due to a 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-1889-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-23
Posted: 2017-04-27
Terminated: 2017-09-26
Recalling firm: Merit Medical Systems, Inc.
Product: 1 mL Medallion Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P.
Product code: FMF Syringe, Piston
Reason for recall: Merit Medical Systems announces a voluntary field action for the 1mL Medallion Syringes due to a defect with the syringe plunger tip.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees began receiving notification via letter on March 23, 2017 to immediately stop using or distributing the affected lots and return them back to Merit. If there are any questions, contact Merit Customer Service at (801) 208-4381.
Quantity in commerce: 23,032 units
Distribution: Nationwide and other foreign consignees. No VA/govt/military or VA consignees.
Product codes and lots: Lot Numbers: B617173, H1082598, H1082648, H1082649, H1082809, H1085511, H1085645, H1092907, H1085649, H1097018, H1085658, H1085659, H1085735, H1089234, H1089419, H1090184, H1101188, H1101443.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1889-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1889-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-03	2017-04-27

Product code FMF

K875196Class IIDisposable Coronary Control Syringe 12CcMerit Medical Systems, Inc. / cleared 1988-02-11

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)