Bag Decanter II, REF 2002S. 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-2640-2024 — Microtek Medical Inc. is recalling Bag Decanter II, REF 2002S. 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: Bag Decanter II, REF 2002S. 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-2640-2024: Microtek Medical Inc. is recalling Bag Decanter II, REF 2002S. 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-2640-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2640-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2640-2024
      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: 2002S/00748426002399; Lot Numbers: 200403,211013,210626,200409,190913,200420,200422,200422,190510,190319,200108,190415,190702,190109,190827,191022,200313,200306,200312,191212,190226,190802,181113,181221,191213,191019,200617,181130,190114,200313,190620,191228,211109,211109,211107,211109,211021,211022,211012,211012,211026,211018,211105,211105,211105,211012,211007,210913,210913,210908,210802,210806,210810,210903,210902,210902,210812,210809,210718,210709,210729,210810,210328,210823,210729,210802,210802,210719,210728,210703,210625,210622,210704,210618,210618,210710,210610,210520,210519,210408,210518,210518,210518,210517,210512,210520,210318,210502,210502,210318,210317,210422,210409,210405,210403,210404,210329,210422,210327,210404,210325,210323,210402,210304,210220,210127,210121,210117,201208,201204,201204,201013,201127,201126,201102,201028,201022,201026,200906,200912,200904,200616,201007,190218,190729,190916,200513,200329,190426,181218,181221,200417,200514,200513,190823,190823,191021,190306,181124,191112,191213,191112,190108,190327,191127,190121,191004,191004,190725,200512,190419,200615,200611,190306,190506,191018,190227,190528,181107,190102,200102,181129,190716,190716,190116,181220,181225,181225,181214,190725,210618,181107,231129,200107,210618,181011,181214,181225,200421,190724,191212,200728,190802,190805,200422,191218,190912,191017,191112,200422,200403,190624,200221,190109,191019,190307,190802,181113,190409,190402,200227,190912,190402,181221,191212,190218,191111,190321,200811,190306,190114,191212,200103,200403,200511,190628,191228,200320,191212,211204,211021,211105,211011,211012,211108,211026,211026,211017,211017,211014,211013,211007,210913,210926,211007,210907,210902,210812,210826,210718,210806,210709,210726,210823,210729,210811,210802,210721,210728,210721,210703,210802,210704,210710,210704,210619,210618,210618,210610,210613,210408,210408,210613,210518,210517,210507,210509,210509,210317,210317,210409,210327,210326,210323,210323,210303,200421…
      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-2640-2024: Microtek Medical Inc. is recalling Bag Decanter II, REF 2002S. 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-2640-2024: Microtek Medical Inc. is voluntarily recalling Bag Decanter II, REF 2002S. 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: 2002S/00748426002399; Lot Numbers: 200403,211013,210626,200409,190913,200420,200422,200422,190510,190319,200108,190415,190702,190109,190827,191022,200313,200306,200312,191212,190226,190802,181113,181221,191213,191019,200617,181130,190114,200313,190620,191228,211109,211109,211107,211109,211021,211022,211012,211012,211026,211018,211105,211105,211105,211012,211007,210913,210913,210908,210802,210806,210810,210903,210902,210902,210812,210809,210718,210709,210729,210810,210328,210823,210729,210802,210802,210719,210728,210703,210625,210622,210704,210618,210618,210710,210610,210520,210519,210408,210518,210518,210518,210517,210512,210520,210318,210502,210502,210318,210317,210422,210409,210405,210403,210404,210329,210422,210327,210404,210325,210323,210402,210304,210220,210127,210121,210117,201208,201204,201204,201013,201127,201126,201102,201028,201022,201026,200906,200912,200904,200616,201007,190218,190729,190916,200513,200329,190426,181218,181221,200417,200514,200513,190823,190823,191021,190306,181124,191112,191213,191112,190108,190327,191127,190121,191004,191004,190725,200512,190419,200615,200611,190306,190506,191018,190227,190528,181107,190102,200102,181129,190716,190716,190116,181220,181225,181225,181214,190725,210618,181107,231129,200107,210618,181011,181214,181225,200421,190724,191212,200728,190802,190805,200422,191218,190912,191017,191112,200422,200403,190624,200221,190109,191019,190307,190802,181113,190409,190402,200227,190912,190402,181221,191212,190218,191…
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-2640-2024 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.