Refer to RES or lead review memo for complete list of affected reference/catalog numbers
type: Dataset
description: FDA recall Z-0635-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Refer to RES or lead review memo for complete list of affected reference/catalog numbers (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: Refer to RES or lead review memo for complete list of affected reference/catalog numbers
  type: MedicalDevice
  manufacturer: MEDLINE INDUSTRIES, LP - Northfield
claims: FDA recall Z-0635-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Refer to RES or lead review memo for complete list of affected reference/catalog numbers
claims: FDA classified recall Z-0635-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0635-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0635-2025
      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: MEDLINE INDUSTRIES, LP - Northfield
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-10-09
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 1) REF CDS780147M, UDI/DI 10193489445510 (each) 40193489445511 (case), Lot Numbers: 22EBM611, 22EBO511; 2) REF CDS860040K, UDI/DI 10195327010447 (each) 40195327010448 (case), Lot Numbers: 22ELA276, 23ALB139, 23ELA269, 23CLB184, 22JLA300; 3) REF CDS980245X, UDI/DI 10193489848434 (each) 40193489848435 (case), Lot Numbers: 22GBS312, 22FBG764, 22KBJ856, 23BBG738; 4) REF CDS980566F, UDI/DI 10193489445442 (each) 40193489445443 (case), Lot Numbers: 22HBJ660, 22GBE251, 22JBF110, 22KBE727, 23ABL563, 23DBD997, 23BBG522, 23GBF733; 5) REF CDS982933N, UDI/DI 10193489879117 (each) 40193489879118 (case), Lot Numbers: 22FBG572, 22JBQ100; 6) REF CDS982936U, UDI/DI 10195327185220 (each) 40195327185221 (case), Lot Numbers: 23ABF691; 7) REF CDS983293F, UDI/DI 10193489590616 (each) 40193489590617 (case), Lot Numbers: 22GBY030; 8) REF CDS983467J, UDI/DI 10195327561116 (each) 40195327561117 (case), Lot Numbers: 24ADC216, 24ADA818, 24BDA929, 24EDA751; 9) REF CDS983470I, UDI/DI 10195327561154 (each) 40195327561155 (case), Lot Numbers: 23LDA393, 24ADC171; 10) REF CDS983477K, UDI/DI 10195327560867 (each) 40195327560868 (case), Lot Numbers: 24ADA523, 24EDA272; 11) REF CDS983479O, UDI/DI 10195327497446 (each) 40195327497447 (case), Lot Numbers: 23KDA634, 23LDB753, 24BDB695; 12) REF CDS983488K, UDI/DI 10195327561147 (each) 40195327561148 (case), Lot Numbers: 24ADA074, 24EDA221; 13) REF CDS983494K, UDI/DI 10195327561123 (each) 40195327561124 (case), Lot Numbers: 23LDB243, 24BDB988; 14) REF CDS983908O, UDI/DI 10193489402773 (each) 40193489402774 (case), Lot Numbers: 22GBT396; 15) REF CDS983914K, UDI/DI 10193489402698 (each) 40193489402699 (case), Lot Numbers: 22EBA061, 22DBU743, 22GBI220; 16) REF CDS984599F, UDI/DI 10193489486148 (each) 40193489486149 (case), Lot Numbers: 22EMH743, 22HMA205, 22GMB332, 22KMF120, 22KMF139, 22HMF967, 23FME358, 23AMI307, 22LMF801, 23GMB934, 23KMF368, 23LMC668; 17) REF CDS984600F, UDI/DI 10193489486100 (each) 40193489486101 (case), Lot Numbers: 22JME533, 22HMH038, 23FM…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide distribution.
      status: recorded

FDA recall Z-0635-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Refer to RES or lead review memo for complete list of affected reference/catalog numbers
type: Claim
text: The FDA logged enforcement record Z-0635-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Refer to RES or lead review memo for complete list of affected reference/catalog numbers — reason: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-10-09. Affected lots/codes: 1) REF CDS780147M, UDI/DI 10193489445510 (each) 40193489445511 (case), Lot Numbers: 22EBM611, 22EBO511; 2) REF CDS860040K, UDI/DI 10195327010447 (each) 40195327010448 (case), Lot Numbers: 22ELA276, 23ALB139, 23ELA269, 23CLB184, 22JLA300; 3) REF CDS980245X, UDI/DI 10193489848434 (each) 40193489848435 (case), Lot Numbers: 22GBS312, 22FBG764, 22KBJ856, 23BBG738; 4) REF CDS980566F, UDI/DI 10193489445442 (each) 40193489445443 (case), Lot Numbers: 22HBJ660, 22GBE251, 22JBF110, 22KBE727, 23ABL563, 23DBD997, 23BBG522, 23GBF733; 5) REF CDS982933N, UDI/DI 10193489879117 (each) 40193489879118 (case), Lot Numbers: 22FBG572, 22JBQ100; 6) REF CDS982936U, UDI/DI 10195327185220 (each) 40195327185221 (case), Lot Numbers: 23ABF691; 7) REF CDS983293F, UDI/DI 10193489590616 (each) 40193489590617 (case), Lot Numbers: 22GBY030; 8) REF CDS983467J, UDI/DI 10195327561116 (each) 40195327561117 (case), Lot Numbers: 24ADC216, 24ADA818, 24BDA929, 24EDA751; 9) REF CDS983470I, UDI/DI 10195327561154 (each) 40195327561155 (case), Lot Numbers: 23LDA393, 24ADC171; 10) REF CDS983477K, UDI/DI 10195327560867 (each) 40195327560868 (case), Lot Numbers: 24ADA523, 24EDA272; 11) REF CDS983479O, UDI/DI 10195327497446 (each) 40195327497447 (case), Lot Numbers: 23KDA634, 23LDB753, 24BDB695; 12) REF CDS983488K, UDI/DI 10195327561147 (each) 40195327561148 (case), Lot Numbers: 24ADA074, 24EDA221; 13) REF CDS983494K, UDI/DI 10195327561123 (each) 40195327561124 (case), Lot Numbers: 23LDB243, 24BDB988; 14) REF CDS983908O, UDI/DI 10193489402773 (each) 4019348940277…
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-0635-2025 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.