Z-0516-2025.jsonld
type: Dataset
name: RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
description: FDA recall Z-0516-2025 — Smith & Nephew Medical, Ltd. is recalling RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials. (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: MedicalDevice
  name: RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
  manufacturer: Smith & Nephew Medical, Ltd.
claims: enforcement-record
claims: FDA classified recall Z-0516-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0516-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0516-2025
      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: Smith & Nephew Medical, Ltd.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-10-02
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Model Numbers: 66803126, 66803126LRC UDI-DI codes: 05000223498634 Serial Numbers: PEAB230001 PEAE230422 PEAF230180 PEAG230269 PEAH230208 PEAH230859 PEAJ230484 PEAB230002 PEAE230423 PEAF230181 PEAG230271 PEAH230209 PEAH230861 PEAJ230490 PEAB230003 PEAE230427 PEAF230185 PEAG230272 PEAH230210 PEAH230862 PEAJ230491 PEAB230006 PEAE230428 PEAF230186 PEAG230273 PEAH230211 PEAH230863 PEAJ230492 PEAB230011 PEAE230429 PEAF230188 PEAG230275 PEAH230212 PEAH230865 PEAJ230493 PEAB230014 PEAE230432 PEAF230189 PEAG230277 PEAH230214 PEAH230867 PEAJ230497 PEAB230021 PEAE230433 PEAF230190 PEAG230279 PEAH230215 PEAH230868 PEAJ230499 PEAB230022 PEAE230434 PEAF230199 PEAG230280 PEAH230216 PEAH230871 PEAJ230502 PEAB230027 PEAE230436 PEAF230202 PEAG230282 PEAH230217 PEAH230872 PEAJ230505 PEAB230028 PEAE230437 PEAF230203 PEAG230283 PEAH230218 PEAH230874 PEAJ230512 PEAB230032 PEAE230438 PEAF230208 PEAG230285 PEAH230219 PEAH230875 PEAJ230513 PEAB230033 PEAE230439 PEAF230209 PEAG230287 PEAH230220 PEAH230876 PEAJ230515 PEAB230036 PEAE230440 PEAF230211 PEAG230288 PEAH230221 PEAH230877 PEAJ230525 PEAB230037 PEAE230441 PEAF230212 PEAG230289 PEAH230222 PEAH230879 PEAJ230526 PEAB230039 PEAE230442 PEAF230217 PEAG230292 PEAH230223 PEAH230882 PEAJ230527 PEAB230041 PEAE230443 PEAF230221 PEAG230294 PEAH230224 PEAH230883 PEAJ230530 PEAB230042 PEAE230448 PEAF230222 PEAG230295 PEAH230225 PEAH230884 PEAJ230532 PEAB230044 PEAE230450 PEAF230226 PEAG230301 PEAH230226 PEAH230885 PEAJ230538 PEAB230048 PEAE230452 PEAF230233 PEAG230303 PEAH230227 PEAH230886 PEAJ230541 PEAB230050 PEAE230454 PEAF230236 PEAG230305 PEAH230228 PEAH230888 PEAJ230542 PEAB230051 PEAE230455 PEAF230237 PEAG230306 PEAH230229 PEAH230889 PEAJ230545 PEAB230052 PEAE230456 PEAF230239 PEAG230307 PEAH230230 PEAH230892 PEAJ230558 PEAB230053 PEAE230458 PEAF230243 PEAG230308 PEAH230231 PEAH230893 PEAJ230563 PEAB230054 PEAE230459 PEAF230247 PEAG230309 PEAH230234 PEAH230896 PEAJ230564 PEAB230057 PEAE230461 PEAF230249 PEAG230313 PEAH230235 PEAH230897 PEAJ…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: Canada
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-0516-2025: Smith & Nephew Medical, Ltd. is recalling RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
text: The FDA logged enforcement record Z-0516-2025: Smith & Nephew Medical, Ltd. is voluntarily recalling RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials. — reason: Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-10-02. Affected lots/codes: Model Numbers: 66803126, 66803126LRC UDI-DI codes: 05000223498634 Serial Numbers: PEAB230001 PEAE230422 PEAF230180 PEAG230269 PEAH230208 PEAH230859 PEAJ230484 PEAB230002 PEAE230423 PEAF230181 PEAG230271 PEAH230209 PEAH230861 PEAJ230490 PEAB230003 PEAE230427 PEAF230185 PEAG230272 PEAH230210 PEAH230862 PEAJ230491 PEAB230006 PEAE230428 PEAF230186 PEAG230273 PEAH230211 PEAH230863 PEAJ230492 PEAB230011 PEAE230429 PEAF230188 PEAG230275 PEAH230212 PEAH230865 PEAJ230493 PEAB230014 PEAE230432 PEAF230189 PEAG230277 PEAH230214 PEAH230867 PEAJ230497 PEAB230021 PEAE230433 PEAF230190 PEAG230279 PEAH230215 PEAH230868 PEAJ230499 PEAB230022 PEAE230434 PEAF230199 PEAG230280 PEAH230216 PEAH230871 PEAJ230502 PEAB230027 PEAE230436 PEAF230202 PEAG230282 PEAH230217 PEAH230872 PEAJ230505 PEAB230028 PEAE230437 PEAF230203 PEAG230283 PEAH230218 PEAH230874 PEAJ230512 PEAB230032 PEAE230438 PEAF230208 PEAG230285 PEAH230219 PEAH230875 PEAJ230513 PEAB230033 PEAE230439 PEAF230209 PEAG230287 PEAH230220 PEAH230876 PEAJ230515 PEAB230036 PEAE230440 PEAF230211 PEAG230288 PEAH230221 PEAH230877 PEAJ230525 PEAB230037 PEAE230441 PEAF230212 PEAG230289 PEAH230222 PEAH230879 PEAJ230526 PEAB230039 PEAE230442 PEAF230217 PEAG230292 PEAH230223 PEAH230882 PEAJ230527 PEAB230041 PEAE230443 PEAF230221 PEAG230294 PEAH230224 PEAH230883 PEAJ230530 PEAB230042 PEAE230448 PEAF230222 PEAG230295 PEAH230225 PEAH230884 PEAJ230532 PEAB230044 PEAE230450 PEAF230226 P…
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-0516-2025 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.