See DocMan
type: Dataset
description: FDA recall Z-0790-2025 — 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-0790-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling See DocMan
claims: FDA classified recall Z-0790-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0790-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0790-2025
      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 CDS780162AA, UDI/DI 10193489262049 (EA) 40193489262040 (CS), Lot Numbers: 20BBO888, 20BBQ352, 20FBR735; 2) REF CDS780162AB, UDI/DI 10193489338447 (EA) 40193489338448 (CS), Lot Numbers: 20GBF853; 3) REF CDS780162AC, UDI/DI 10193489383911 (EA) 40193489383912 (CS), Lot Numbers: 20HBE537, 20IBB263, 20JBB811, 20KBA268, 20LBM232, 21ABA833; 4) REF CDS780162AD, UDI/DI 10193489498950 (EA) 40193489498951 (CS), Lot Numbers: 21ABU170, 21BBQ045, 21DBD059, 21DBS617, 21GBS609, 21HBB525; 5) REF CDS780162X, UDI/DI 10889942840281 (EA) 40889942840282 (CS), Lot Numbers: 19ABX591, 19BBM085, 19CBM932, 19EBF768, 19EBU016, 19EBY613, 19FBI652, 19GBV765; 6) REF CDS780162Y, UDI/DI 10193489694079 (EA) 40193489694070 (CS), Lot Numbers: 19HBC545, 19HBD425, 19JBG849, 19LBO181, 19RBB546, 19VBH579; 7) REF CDS780208F, UDI/DI 10193489494211 (EA) 40193489494212 (CS), Lot Numbers: 21FBD429, 22ABH903, 22BBQ627, 22DBL468, 22EBM543, 22HBH464, 22IBN540, 22KBM775, 23ABM574, 23ABU440; 8) REF CDS981327N, UDI/DI 10889942959273 (EA) 40889942959274 (CS), Lot Numbers: 19ABN030, 19DBH383, 19EBJ379, 19GBI961, 19HBU954, 19JBK986, 19LBW564, 20CBH905, 20EBS213, 20GBU395; 9) REF CDS981327O, UDI/DI 10193489396782 (EA) 40193489396783 (CS), Lot Numbers: 20JBO709, 20LBM343, 20LBM792, 21CBE183, 21DBJ732; 10) REF CDS981327P, UDI/DI 10193489930825 (EA) 40193489930826 (CS), Lot Numbers: 21KBO532, 22ABE609; 11) REF CDS981327Q, UDI/DI 10195327080365 (EA) 40195327080366 (CS), Lot Numbers: 22BMC351, 22BMG728, 22FMF883, 22FMH830, 22GMH480, 22IMA515, 22KMF960, 22KMF961, 22LMC560, 23BMG193, 23BMG197, 23BMH848, 23CMF104, 23FMF213, 23GME170, 23IMB313, 23IMG472, 23JMG480, 23KMF371; 12) REF CDS982683Q, UDI/DI 10193489463668 (EA) 40193489463669 (CS), Lot Numbers: 21IBO697, 21IBW821, 21JBQ897, 21KBX752, 21LBI690, 22ABL244, 22EBL552, 22FBN421, 22OBC365, 13) REF CDS983383F, UDI/DI 10889942654956 (EA) 40889942654957 (CS), Lot Numbers: 19BBK956, 19CBT696, 19FBQ922, 19GBO356, 19IBN865, 19KBC420, 19PBC874, 19SBE336, 20ABR692, 20BBT769, 20…
      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-0790-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling See DocMan
type: Claim
text: The FDA logged enforcement record Z-0790-2025: 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 CDS780162AA, UDI/DI 10193489262049 (EA) 40193489262040 (CS), Lot Numbers: 20BBO888, 20BBQ352, 20FBR735; 2) REF CDS780162AB, UDI/DI 10193489338447 (EA) 40193489338448 (CS), Lot Numbers: 20GBF853; 3) REF CDS780162AC, UDI/DI 10193489383911 (EA) 40193489383912 (CS), Lot Numbers: 20HBE537, 20IBB263, 20JBB811, 20KBA268, 20LBM232, 21ABA833; 4) REF CDS780162AD, UDI/DI 10193489498950 (EA) 40193489498951 (CS), Lot Numbers: 21ABU170, 21BBQ045, 21DBD059, 21DBS617, 21GBS609, 21HBB525; 5) REF CDS780162X, UDI/DI 10889942840281 (EA) 40889942840282 (CS), Lot Numbers: 19ABX591, 19BBM085, 19CBM932, 19EBF768, 19EBU016, 19EBY613, 19FBI652, 19GBV765; 6) REF CDS780162Y, UDI/DI 10193489694079 (EA) 40193489694070 (CS), Lot Numbers: 19HBC545, 19HBD425, 19JBG849, 19LBO181, 19RBB546, 19VBH579; 7) REF CDS780208F, UDI/DI 10193489494211 (EA) 40193489494212 (CS), Lot Numbers: 21FBD429, 22ABH903, 22BBQ627, 22DBL468, 22EBM543, 22HBH464, 22IBN540, 22KBM775, 23ABM574, 23ABU440; 8) REF CDS981327N, UDI/DI 10889942959273 (EA) 40889942959274 (CS), Lot Numbers: 19ABN030, 19DBH383, 19EBJ379, 19GBI961, 19HBU954, 19JBK986, 19LBW564, 20CBH905, 20EBS213, 20GBU395; 9) REF CDS981327O, UDI/DI 10193489396782 (EA) 40193489396783 (CS), Lot Numbers: 20JBO709, 20LBM343, 20LBM792, 21CBE183, 21DBJ732; 10) REF CDS981327P, UDI/DI 10193489930825 (EA) 40193489930826 (CS), Lot Numbers: 21KBO532, 22ABE609; 11) REF CDS981327Q, UDI/DI 10195327080365 (EA) 40195327080366 (CS), Lot Numbers: 22BMC351, 22BMG728, 22FMF883, 22FMH830, 22GMH480, 22IMA515, 22KMF960, 22KMF961, 22LMC560, 23BMG193, 23BMG197, 23BMH848, 23CMF104, 23FMF213, 23G…
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-0790-2025 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.