Transfer Device, REF 2008S. 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-2643-2024 — Microtek Medical Inc. is recalling Transfer Device, REF 2008S. 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: Transfer Device, REF 2008S. 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-2643-2024: Microtek Medical Inc. is recalling Transfer Device, REF 2008S. 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-2643-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2643-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2643-2024
      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: 2008S/00748426002535; Lot Numbers: 210924,190828,190828,190312,190527,190507,190528,190507,181022,190527,181224,190717,181226,181225,190312,190828,190410,180828,190527,190528,180828,181226,211115,210924,210922,210922,210922,210923,210924,210922,210807,210805,210706,210706,210922,210706,210804,210804,210419,210419,210419,210415,210415,210415,210416,210416,210419,210104,210104,210104,201111,201111,201110,201110,201113,201113,201113,201113,201112,201112,201112,201112,201112,201113,201019,201019,201019,200818,200818,200818,200818,200818,200702,200702,200702,200702,190528,190312,181022,190527,190828,181225,181224,190410,190829,181224,180828,190527,190312,181022,181022,181226,190718,180828,190528,190313,190527,181224,181226,181226,190717,181225,181226,230628,230626,230608,230623,230608,230626,230607,230509,230605,230605,230605,230509,230509,230324,230324,230326,230325,230325,221117,221117,221112,221112,221112,221006,211116,211115,211115,211115,220525,220525,220417,220406,220527,220527,220527,220527,220530,220527,220530,220407,220405,220407,220103,220103,220102,220102,220102,181226,190410,190507,190410,211116,211117,210924,210922,210924,210922,210922,210923,210923,210807,210924,210807,210807,210924,210706,210924,210706,210706,210805,210419,210804,210706,210419,210419,210415,210415,210416,210416,210415,210416,210416,210104,210104,210419,210104,201111,201111,201111,201110,201110,201110,201113,201113,201112,201020,201019,200818,190527,190410,230628,230628,230626,230629,230626,230629,230623,230623,230623,230324,230325,230326,221117,220526,211115,220406,220526,220530,220527,220527,220407,220405,220406,220405,220103,220103,220103,220103,200424,190507,181226,230628,230629,230608,230509,220103,220103,210415,181225,211117,210924,201111,201112,200702,181225,190718,230628,190312,181225,181226,180828,181225,181225,211117,211117,211117,211117,211116,210924,210923,210416,200424,210924,210923,210805,210805,210706,210706,210805,210804,210419,210419,210416,210416…
      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-2643-2024: Microtek Medical Inc. is recalling Transfer Device, REF 2008S. 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-2643-2024: Microtek Medical Inc. is voluntarily recalling Transfer Device, REF 2008S. 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: 2008S/00748426002535; Lot Numbers: 210924,190828,190828,190312,190527,190507,190528,190507,181022,190527,181224,190717,181226,181225,190312,190828,190410,180828,190527,190528,180828,181226,211115,210924,210922,210922,210922,210923,210924,210922,210807,210805,210706,210706,210922,210706,210804,210804,210419,210419,210419,210415,210415,210415,210416,210416,210419,210104,210104,210104,201111,201111,201110,201110,201113,201113,201113,201113,201112,201112,201112,201112,201112,201113,201019,201019,201019,200818,200818,200818,200818,200818,200702,200702,200702,200702,190528,190312,181022,190527,190828,181225,181224,190410,190829,181224,180828,190527,190312,181022,181022,181226,190718,180828,190528,190313,190527,181224,181226,181226,190717,181225,181226,230628,230626,230608,230623,230608,230626,230607,230509,230605,230605,230605,230509,230509,230324,230324,230326,230325,230325,221117,221117,221112,221112,221112,221006,211116,211115,211115,211115,220525,220525,220417,220406,220527,220527,220527,220527,220530,220527,220530,220407,220405,220407,220103,220103,220102,220102,220102,181226,190410,190507,190410,211116,211117,210924,210922,210924,210922,210922,210923,210923,210807,210924,210807,210807,210924,210706,210924,210706,210706,210805,210419,210804,210706,210419,210419,210415,210415,210416,210416,210415,210416,210416,210104,210104,210419,210104,201111,201111,201111,201110,201110,201110,201113,201113,201112,201020,201019,200818,190527,190410,230628,230628,230626,230…
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-2643-2024 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.