see RES for description
type: Dataset
description: FDA recall Z-2624-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling see RES for description (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 RES for description
  type: MedicalDevice
  manufacturer: MEDLINE INDUSTRIES, LP - Northfield
claims: FDA recall Z-2624-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling see RES for description
claims: FDA classified recall Z-2624-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2624-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2624-2024
      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: MEDLINE INDUSTRIES, LP - Northfield
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-04-08
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: CDS985445B , Lot Number19ABK040 ; CDS985445B , Lot Number19ABV498 ; CDS985445B , Lot Number19BBN825 ; CDS985445B , Lot Number19EBG359 ; CDS985445B , Lot Number19FBA393 ; CDS985445B , Lot Number19GBC446 ; CDS985445B , Lot Number19HBM036 ; CDS985445B , Lot Number19JBS476 ; CDS985445B , Lot Number19LBC804 ; CDS985445B , Lot Number20BBA618 ; CDS985445B , Lot Number20CBI761 ; CDS985445B , Lot Number20DBM201 ; CDS985445B , Lot Number21ABX275 ; CDS985445B , Lot Number21CBG480 ; CDS985445B , Lot Number21CBV955 ; CDS985445B , Lot Number21DBQ516 ; CDS985445C , Lot Number21IBP827 ; CDS985445C , Lot Number21KBO008 ; CDS985445C , Lot Number22BBK102 ; CDS985445C , Lot Number22OBI304 ; CDS985445C , Lot Number22EBI120 ; CDS985445C , Lot Number22GBP605 ; CDS985445C , Lot Number22GBU597 ; CDS985445C , Lot Number22GBY036 ; CDS985445C , Lot Number22HMG268 ; CDS985445C , Lot Number22HMH893 ; CDS985445C , Lot Number22JME066 ; CDS985445C , Lot Number22KMC551 ; CDS985445C , Lot Number22LMA461 ; CDS985445C , Lot Number22LMC730 ; CDS985445C , Lot Number23AMG434 ; CDS985445C , Lot Number23FMC235 ; CDS985445C , Lot Number23GME307 ; CDS985445C , Lot Number23JMF730 ; DYNDA1233B , Lot Number21JBQ010 ; DYNDA2402A , Lot Number22JBE471 ; DYNDA2402A , Lot Number22JBH025 ; DYNDA2402A , Lot Number22KBU699 ; DYNDA2402A , Lot Number23ABN842 ; DYNDA2402A , Lot Number23CBM334 ; DYNDA2402A , Lot Number23EBS527 ; DYNDA2402A , Lot Number23HBL655 ; DYNDA2402A , Lot Number23HBZ380 ; DYNDA2402A , Lot Number23IBO904 ; DYNDA2402A , Lot Number23KBE880 ; DYNDA2795, Lot Number21HBS958 ; DYNDH1094, Lot Number22NBD305 ; DYNDH1094, Lot Number22DBE033 ; DYNDH1094, Lot Number20ABB780 ; DYNDH1094, Lot Number21DBO182 ; DYNDH1351B , Lot Number23IBK337 ; DYNDH1351B , Lot Number23IBP041 ; DYNDH1351B , Lot Number24ABU967 ; DYNDH1697, Lot Number22OBC291 ; DYNDH1697A , Lot Number22EBO835 ; DYNDH1697A , Lot Number22GBG348 ; DYNDH1697A , Lot Number22GBT117 ; DYNDH1697A , Lot Number22HBK868 ; DYNDH1697A , Lot Number22LBK070 ; DYNDH1…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution.
      status: recorded

FDA recall Z-2624-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling see RES for description
type: Claim
text: The FDA logged enforcement record Z-2624-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling see RES for description — reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-08. Affected lots/codes: CDS985445B , Lot Number19ABK040 ; CDS985445B , Lot Number19ABV498 ; CDS985445B , Lot Number19BBN825 ; CDS985445B , Lot Number19EBG359 ; CDS985445B , Lot Number19FBA393 ; CDS985445B , Lot Number19GBC446 ; CDS985445B , Lot Number19HBM036 ; CDS985445B , Lot Number19JBS476 ; CDS985445B , Lot Number19LBC804 ; CDS985445B , Lot Number20BBA618 ; CDS985445B , Lot Number20CBI761 ; CDS985445B , Lot Number20DBM201 ; CDS985445B , Lot Number21ABX275 ; CDS985445B , Lot Number21CBG480 ; CDS985445B , Lot Number21CBV955 ; CDS985445B , Lot Number21DBQ516 ; CDS985445C , Lot Number21IBP827 ; CDS985445C , Lot Number21KBO008 ; CDS985445C , Lot Number22BBK102 ; CDS985445C , Lot Number22OBI304 ; CDS985445C , Lot Number22EBI120 ; CDS985445C , Lot Number22GBP605 ; CDS985445C , Lot Number22GBU597 ; CDS985445C , Lot Number22GBY036 ; CDS985445C , Lot Number22HMG268 ; CDS985445C , Lot Number22HMH893 ; CDS985445C , Lot Number22JME066 ; CDS985445C , Lot Number22KMC551 ; CDS985445C , Lot Number22LMA461 ; CDS985445C , Lot Number22LMC730 ; CDS985445C , Lot Number23AMG434 ; CDS985445C , Lot Number23FMC235 ; CDS985445C , Lot Number23GME307 ; CDS985445C , Lot Number23JMF730 ; DYNDA1233B , Lot Number21JBQ010 ; DYNDA2402A , Lot Number22JBE471 ; DYNDA2402A , Lot Number22JBH025 ; DYNDA2402A , Lot Number22KBU699 ; DYNDA2402A , Lot Number23ABN842 ; DYNDA2402A , Lot Number23CBM334 ; DYNDA2402A , Lot Number23EBS527 ; DYNDA2402A , Lot Number23HBL655 ; DYNDA2402A , Lot Number23HBZ380 ; DYNDA2402A , Lot Number23IBO904 ; DYNDA2402A , Lot Number23KBE880 ; DYNDA2795, Lo…
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-2624-2024 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.