Z-0635-2017Class II

Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A

Name: Z-0635-2017 Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Creator: Merit Medical Systems, Inc.
Published: 2016-09-23
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2016-09-23 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A on 2016-09-23. FDA classified it as Class II and gives the reason as "Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier". 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-0635-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-23
Posted: 2016-11-19
Terminated: 2017-03-27
Recalling firm: Merit Medical Systems, Inc.
Product: Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Product code: OJV Single Use Instrument Tray
Reason for recall: Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees notified via letter on 09/23/16 to quarantine any devices and discontinue use, ensure all personnel to whom the devices were distributed are made aware of the field action, and return affected devices to Merit Medical.
Quantity in commerce: 53 units
Distribution: Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
Product codes and lots: Lot Numbers: H992344 and H996476

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0635-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0631-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19
Z-0632-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19
Z-0633-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19
Z-0634-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19
Z-0635-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19

Product code OJV

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)