RecallRadar

FDA Device recall Z-0002-2017

Merit Inflation Syringe Kit

On 2016-10-12 the FDA classified a Class II recall of Merit Inflation Syringe Kit by Merit Medical Systems, citing merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0002-2017
ClassificationClass II
Statusterminated
Initiated2016-08-25
Published2016-10-12
Last updated2026-09-13 11:54 UTC
CompanyMerit Medical Systems
DistributionCA, VA

Product

Merit Inflation Syringe Kit. Catalog Number KOS-02857

Reason

Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.

Identifiers

code_infoLot Numbers: H959038, H970334, H984351.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0002-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.