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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80650

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 02, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Merit Medical Systems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2742-2018
Recall number
Z-2742-2018
Initiated
February 02, 2018
Classification
Class II
Status
Terminated
Quantity
22,234

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Supplier manufacturing defect with the syringe plunger tip.

Code information

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.

Distribution pattern

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.