See DocMan
type: Dataset
description: FDA recall Z-0788-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling See DocMan (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: See DocMan
  type: MedicalDevice
  manufacturer: MEDLINE INDUSTRIES, LP - Northfield
claims: FDA recall Z-0788-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling See DocMan
claims: FDA classified recall Z-0788-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0788-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0788-2025
      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: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-11-21
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 1) REF CDS930177C, UDI/DI 10889942810949 (EA) 40889942810940 (CS), Lot Numbers: 19BBO293, 19CBI818, 19EBC020, 19IBS311, 19JBP366, 19LBY043, 19VBE320, 20CBD448, 21ABE744, 21BBN653; 2) REF CDS982054V, UDI/DI 10193489552799 (EA) 40193489552790 (CS), Lot Numbers: 19BBJ530, 19CBL695, 19EBN805, 19EBZ133; 3) REF CDS982683X, UDI/DI 10198459064548 (EA) 40198459064549 (CS), Lot Numbers: 24IBH460; 4) REF CDS982719X, UDI/DI 10198459064531 (EA) 40198459064532 (CS), Lot Numbers: 24IBE288, 24JBB766, 24KBA129; 5) REF CDS983467J, UDI/DI 10195327561116 (EA) 40195327561117 (CS), Lot Numbers: 24ADA818, 24ADC216, 24BDA929, 24DDB447, 24EDA275, 24EDA751, 24GDB213, 24IDA327, 24IDB043, 24IDB372; 6) REF CDS983470C, UDI/DI 10889942730407 (EA) 40889942730408 (CS), Lot Numbers: 19ADC620, 19BDA241, 19CDA866, 19DDA314, 19DDD395, 19FDB295, 19GDA719, 19HDD614, 19JDB841, 19LDB812; 7) REF CDS983470I, UDI/DI 10195327561154 (EA) 40195327561155 (CS), Lot Numbers: 23LDA393, 24ADC171, 24DDA672, 24EDB254, 24FDC148, 24IDB368; 8) REF CDS983799D, UDI/DI 10193489592030 (EA) 40193489592031 (CS), Lot Numbers: 19FKB592, 19HKC268, 19IKA490, 19IKB968, 19JKA055, 19KKC040, 19LKB631, 20CKA736, 20HKB175, 21FLA865, 21ILA106, 21KLA781, 22ILA060, 22ILA292, 23HLA184; 9) REF CDS985212A, UDI/DI 10193489596335 (EA) 40193489596336 (CS), Lot Numbers: 19ABY900, 19FBT060, 19IBL327, 19PBA051; 10) REF CDS985212B, UDI/DI 10193489779820 (EA) 40193489779821 (CS), Lot Numbers: 19LBU107, 19VBH315, 20BBO078, 20CBW525, 20DBT438, 20GBH006, 20IBN419, 21ABB097; 11) REF DYNDA2792, UDI/DI 10193489823325 (EA) 40193489823326 (CS), Lot Numbers: 21BBJ965, 21DBT050, 21EBE485; 12) REF DYNJ0140935G, UDI/DI 10889942930296 (EA) 40889942930297 (CS), Lot Numbers: 19ABO819, 19CBJ281, 19FBH068, 19GBZ882, 19HBV422, 19IBG846, 19JBL457, 20ABG080, 20CBD873, 20DBC392, 20FBA716, 20GBK071, 20HBR714, 20IBM990, 21ABP831, 21BBR277, 21DBA991; 13) REF DYNJ0281906P, UDI/DI 10889942867486 (EA) 40889942867487 (CS), Lot Numbers: 19AKB833, 19BKD052, 19CKC664, 19EKB037, 19F…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
      status: recorded

FDA recall Z-0788-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling See DocMan
type: Claim
text: The FDA logged enforcement record Z-0788-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling See DocMan — reason: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-21. Affected lots/codes: 1) REF CDS930177C, UDI/DI 10889942810949 (EA) 40889942810940 (CS), Lot Numbers: 19BBO293, 19CBI818, 19EBC020, 19IBS311, 19JBP366, 19LBY043, 19VBE320, 20CBD448, 21ABE744, 21BBN653; 2) REF CDS982054V, UDI/DI 10193489552799 (EA) 40193489552790 (CS), Lot Numbers: 19BBJ530, 19CBL695, 19EBN805, 19EBZ133; 3) REF CDS982683X, UDI/DI 10198459064548 (EA) 40198459064549 (CS), Lot Numbers: 24IBH460; 4) REF CDS982719X, UDI/DI 10198459064531 (EA) 40198459064532 (CS), Lot Numbers: 24IBE288, 24JBB766, 24KBA129; 5) REF CDS983467J, UDI/DI 10195327561116 (EA) 40195327561117 (CS), Lot Numbers: 24ADA818, 24ADC216, 24BDA929, 24DDB447, 24EDA275, 24EDA751, 24GDB213, 24IDA327, 24IDB043, 24IDB372; 6) REF CDS983470C, UDI/DI 10889942730407 (EA) 40889942730408 (CS), Lot Numbers: 19ADC620, 19BDA241, 19CDA866, 19DDA314, 19DDD395, 19FDB295, 19GDA719, 19HDD614, 19JDB841, 19LDB812; 7) REF CDS983470I, UDI/DI 10195327561154 (EA) 40195327561155 (CS), Lot Numbers: 23LDA393, 24ADC171, 24DDA672, 24EDB254, 24FDC148, 24IDB368; 8) REF CDS983799D, UDI/DI 10193489592030 (EA) 40193489592031 (CS), Lot Numbers: 19FKB592, 19HKC268, 19IKA490, 19IKB968, 19JKA055, 19KKC040, 19LKB631, 20CKA736, 20HKB175, 21FLA865, 21ILA106, 21KLA781, 22ILA060, 22ILA292, 23HLA184; 9) REF CDS985212A, UDI/DI 10193489596335 (EA) 40193489596336 (CS), Lot Numbers: 19ABY900, 19FBT060, 19IBL327, 19PBA051; 10) REF CDS985212B, UDI/DI 10193489779820 (EA) 40193489779821 (CS), Lot Numbers: 19LBU107, 19VBH315, 20BBO078, 20CBW525, 20DBT438, 20GBH006, 20IBN419, 21ABB097; 11) REF DYNDA2792, UDI/DI 10193489823325 (EA) 40193489823326 (CS), Lot Numbers: 21BBJ965…
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-0788-2025 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.