Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
type: Dataset
description: FDA recall Z-2642-2024 — Microtek Medical Inc. is recalling Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs). (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
  type: MedicalDevice
  manufacturer: Microtek Medical Inc.
claims: FDA recall Z-2642-2024: Microtek Medical Inc. is recalling Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
claims: FDA classified recall Z-2642-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2642-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2642-2024
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: Microtek Medical Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-06-03
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: SKU/UDI-Device Identifier: 2006S/00748426002511; Lot Numbers: 191216,191122,211019,210916,210604,210313,201017,181211,181212,191211,190627,190812,190617,200506,190531,190618,190808,210503,190609,190808,191216,190609,190722,190307,191015,190513,190524,190703,190808,190807,190531,200402,190326,221029,220920,220914,220427,220404,220420,230612,230607,231028,230320,230320,221207,221027,221027,221008,220926,220920,220914,220909,220515,211111,220322,220408,211117,210708,211023,210523,210313,210523,210308,210114,201017,191216,191026,190925,190513,190808,181212,190808,191216,201008,190530,191107,190910,200505,191119,200320,181108,191216,181108,181212,190423,200618,190531,190927,191218,190627,190423,190531,200804,200218,190627,190424,200507,191011,211113,211103,211023,210910,210909,210708,210605,210413,210412,210412,210412,210319,210126,210114,210218,210107,201010,201006,201006,200605,181126,190722,191024,191024,191205,191011,200819,190609,190609,181212,191024,190910,200106,191024,190905,191120,181121,190926,191227,190513,200324,190531,200504,190812,190424,181023,231204,231204,231107,231107,231014,230707,230707,230515,230413,230328,221221,221216,221029,221028,221020,221018,221008,220928,221122,220923,220924,220922,220914,220505,220515,220504,200820,200602,200414,190609,200804,191216,190311,200905,181121,181112,181108,181203,200318,190104,191216,200605,190424,200226,190812,181212,191122,191107,200824,191205,190530,200605,191122,191122,191120,190910,200320,200210,190311,200605,181211,181203,200824,200403,200226,191205,190326,190531,211009,211110,210708,211113,211113,211110,211110,211103,210311,210604,210708,211113,211020,210915,210803,210915,211020,210911,210803,210712,210503,210712,211010,210916,210803,211010,210916,210910,210909,210722,210722,210713,210707,210708,210605,210605,210604,210523,210604,210603,210523,210523,210523,210510,210524,210524,210503,210524,210503,210413,210412,210319,210410,210410,210319,210319,210410,210412,210410,2103067,210313,210312,210311,210308,21030…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.
      status: recorded

FDA recall Z-2642-2024: Microtek Medical Inc. is recalling Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
type: Claim
text: The FDA logged enforcement record Z-2642-2024: Microtek Medical Inc. is voluntarily recalling Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs). — reason: During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-06-03. Affected lots/codes: SKU/UDI-Device Identifier: 2006S/00748426002511; Lot Numbers: 191216,191122,211019,210916,210604,210313,201017,181211,181212,191211,190627,190812,190617,200506,190531,190618,190808,210503,190609,190808,191216,190609,190722,190307,191015,190513,190524,190703,190808,190807,190531,200402,190326,221029,220920,220914,220427,220404,220420,230612,230607,231028,230320,230320,221207,221027,221027,221008,220926,220920,220914,220909,220515,211111,220322,220408,211117,210708,211023,210523,210313,210523,210308,210114,201017,191216,191026,190925,190513,190808,181212,190808,191216,201008,190530,191107,190910,200505,191119,200320,181108,191216,181108,181212,190423,200618,190531,190927,191218,190627,190423,190531,200804,200218,190627,190424,200507,191011,211113,211103,211023,210910,210909,210708,210605,210413,210412,210412,210412,210319,210126,210114,210218,210107,201010,201006,201006,200605,181126,190722,191024,191024,191205,191011,200819,190609,190609,181212,191024,190910,200106,191024,190905,191120,181121,190926,191227,190513,200324,190531,200504,190812,190424,181023,231204,231204,231107,231107,231014,230707,230707,230515,230413,230328,221221,221216,221029,221028,221020,221018,221008,220928,221122,220923,220924,220922,220914,220505,220515,220504,200820,200602,200414,190609,200804,191216,190311,200905,181121,181112,181108,181203,200318,190104,191216,200605,190424,200226,190812,181212,191122,191107,200824,191205,190530,200605,191122,191122,191120,190910,200320,200210,190311,200605,181211,181203,20082…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-2642-2024 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.