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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1310-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Numerous models of nonsterile hemostatic forceps:    (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM;  (2) REF BH304R, Pean Artery Forceps Straight 140MM;  (3) REF BH813R, Artery Forceps Curved 250MM;  (4) REF BJ016R, Diss.A.Ligat.Forceps S-Shaped CVD.210MM;  (5) REF BJ020R, Overholt-Geiss Suture FCPS #0CVD195MM;  (6) REF BJ021R, Overholt-Geiss Suture FCPS #1CVD205MM;  (7) REF BJ022R, Overholt-Geiss Suture FCPS #2CVD220MM;  (8) REF BJ023R, Overholt-Geiss Suture FCPS #3 CVD225MM;  (9) REF BJ025R, Overholt-Geiss Suture FCPS #5CVD230MM;  (10) REF BJ026R, Overholt-Geiss Suture FCPS #6 CVD225MM;  (11) REF BJ031R, Overholt-Geiss Suture FCPS#1CVD260MM;  (12) REF BJ034R, Overholt-Geiss Suture FCPS#4CVD270MM;  (13) REF BJ035R, Overholt-Geiss Suture FCPS #5CVD280MM;  (14) REF BJ037R, Forceps CVD Delicate 145MM;  (15) REF BJ038R, Forceps CVD.Delicate 185MM;  (16) REF BJ039R, Forceps CVD.Delicate 235MM;  (17) REF BJ041R, Rumel Suture Forceps SLT-CVD 240MM;  (18) REF BJ042R, Rumel Suture Forceps CVD 240MM;  (19) REF BJ043R, Rumel Suture Forceps MED-CV 240MM;  (20) REF BJ044R, Rumel Suture Forceps HVY-CV 240MM;  (21) REF BJ045R, Rumel Suture Forceps RT-ANG# 5 240MM;  (22) REF BJ047R, Zenker Suture Forceps SLT-CVD 300MM;  (23) REF BJ048R, Zenker Suture Forceps HVY-CVD 290MM;  (24) REF BJ050R, Mixter-O'Shaugnessy Forceps CVD190MM;  (25) REF BJ051R, Wikstroem Suture Forceps RT-ANG 205MM;  (26) REF BJ052R, Finochietto Suture FCPCVDW/HOLE245MM;  (27) REF BJ055R, Mixter Suture Forceps Rt-Ang 230MM;  (28) REF BJ057R, Kantrowitz Thoracic Clamp 200MM;  (29) REF BJ058R, Kantrowitz Thoracic Clamp 245MM;  (30) REF BJ059R, Kantrowitz Thoracic Clamp 275MM;  (31) REF BJ060R, Lahey Forceps Long-Serr 225MM;  (32) REF BJ061R, Mixter Forceps Long-Serr220MM;  (33) REF BJ062R, Mixter Forceps Long-Serr 250MM;  (34) REF BJ068R, Lahey DISS.A.LIGAT.FORCEPS 230MM;  (35) REF BJ070R, Lawrence Suture FCPS DEL CVDD 270MM;  (36) REF BJ073R, Mixter Forceps Long-Serr 290MM;  (37) REF BJ080R, Overholt Forceps # 0 CVD215MM;  (38) REF BJ081R, Overholt Forceps # 1 CVD210MM;  (39) REF BJ082R, Overholt Forceps # 2 CVD 220MM;  (40) REF BJ083R, Overholt Forceps # 3 CVD 225MM;  (41) REF BJ086R, Overholt Forceps # 6 CVD 225MM;  (42) REF BJ090R, Overholt Forceps # 0 CVD 295MM;  (43) REF BJ091R, Overholt Forceps # 1 CVD 295MM;  (44) REF BJ096R, Overholt Forceps # 6 CVD 300MM;  (45) REF BJ100R, Gemini Clamp RT-ANG140MM;  (46) REF BJ102R, Gemini Clamp RT-ANG 180MM;  (47) REF BJ103R, Gemini Clamp RT-ANG 200MM;  (48) REF BJ104R, Gemini Clamp RT-ANG 230MM;  (49) REF BJ106R, Gemini Clamp RT-ANG 280MM;  (50) REF BJ120R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 160MM;  (51) REF BJ121R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 180MM;  (52) REF BJ122R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 200MM;  (53) REF BJ123R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 220MM;  (54) REF BJ130R, Zenker DISS & LIG FCPSSLT-CVD 350MM;  (55) REF BJ131R, Zenker DISS & LIG FCPS CVD 350MM;  continued",
  "description": "FDA recall Z-1310-2025 — Aesculap Inc is recalling Numerous models of nonsterile hemostatic forceps:    (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM;  (2) REF BH304R, Pean Artery Forceps Straight 140MM;  (3) REF BH813R, Artery Forceps Curved 250MM;  (4) REF BJ016R, Diss.A.Ligat.Forceps S-Shaped CVD.210MM;  (5) REF BJ020R, Overholt-Geiss Suture FCPS #0CVD195MM;  (6) REF BJ021R, Overholt-Geiss Suture FCPS #1CVD205MM;  (7) REF BJ022R, Overholt-Geiss Suture FCPS #2CVD220MM;  (8) REF BJ023R, Overholt-Geiss Suture FCPS #3 CVD225MM;  (9) REF BJ025R, Overholt-Geiss Suture FCPS #5CVD230MM;  (10) REF BJ026R, Overholt-Geiss Suture FCPS #6 CVD225MM;  (11) REF BJ031R, Overholt-Geiss Suture FCPS#1CVD260MM;  (12) REF BJ034R, Overholt-Geiss Suture FCPS#4CVD270MM;  (13) REF BJ035R, Overholt-Geiss Suture FCPS #5CVD280MM;  (14) REF BJ037R, Forceps CVD Delicate 145MM;  (15) REF BJ038R, Forceps CVD.Delicate 185MM;  (16) REF BJ039R, Forceps CVD.Delicate 235MM;  (17) REF BJ041R, Rumel Suture Forceps SLT-CVD 240MM;  (18) REF BJ042R, Rumel Suture Forceps CVD 240MM;  (19) REF BJ043R, Rumel Suture Forceps MED-CV 240MM;  (20) REF BJ044R, Rumel Suture Forceps HVY-CV 240MM;  (21) REF BJ045R, Rumel Suture Forceps RT-ANG# 5 240MM;  (22) REF BJ047R, Zenker Suture Forceps SLT-CVD 300MM;  (23) REF BJ048R, Zenker Suture Forceps HVY-CVD 290MM;  (24) REF BJ050R, Mixter-O'Shaugnessy Forceps CVD190MM;  (25) REF BJ051R, Wikstroem Suture Forceps RT-ANG 205MM;  (26) REF BJ052R, Finochietto Suture FCPCVDW/HOLE245MM;  (27) REF BJ055R, Mixter Suture Forceps Rt-Ang 230MM;  (28) REF BJ057R, Kantrowitz Thoracic Clamp 200MM;  (29) REF BJ058R, Kantrowitz Thoracic Clamp 245MM;  (30) REF BJ059R, Kantrowitz Thoracic Clamp 275MM;  (31) REF BJ060R, Lahey Forceps Long-Serr 225MM;  (32) REF BJ061R, Mixter Forceps Long-Serr220MM;  (33) REF BJ062R, Mixter Forceps Long-Serr 250MM;  (34) REF BJ068R, Lahey DISS.A.LIGAT.FORCEPS 230MM;  (35) REF BJ070R, Lawrence Suture FCPS DEL CVDD 270MM;  (36) REF BJ073R, Mixter Forceps Long-Serr 290MM;  (37) REF BJ080R, Overholt Forceps # 0 CVD215MM;  (38) REF BJ081R, Overholt Forceps # 1 CVD210MM;  (39) REF BJ082R, Overholt Forceps # 2 CVD 220MM;  (40) REF BJ083R, Overholt Forceps # 3 CVD 225MM;  (41) REF BJ086R, Overholt Forceps # 6 CVD 225MM;  (42) REF BJ090R, Overholt Forceps # 0 CVD 295MM;  (43) REF BJ091R, Overholt Forceps # 1 CVD 295MM;  (44) REF BJ096R, Overholt Forceps # 6 CVD 300MM;  (45) REF BJ100R, Gemini Clamp RT-ANG140MM;  (46) REF BJ102R, Gemini Clamp RT-ANG 180MM;  (47) REF BJ103R, Gemini Clamp RT-ANG 200MM;  (48) REF BJ104R, Gemini Clamp RT-ANG 230MM;  (49) REF BJ106R, Gemini Clamp RT-ANG 280MM;  (50) REF BJ120R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 160MM;  (51) REF BJ121R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 180MM;  (52) REF BJ122R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 200MM;  (53) REF BJ123R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 220MM;  (54) REF BJ130R, Zenker DISS & LIG FCPSSLT-CVD 350MM;  (55) REF BJ131R, Zenker DISS & LIG FCPS CVD 350MM;  continued (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/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1310-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Numerous models of nonsterile hemostatic forceps:    (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM;  (2) REF BH304R, Pean Artery Forceps Straight 140MM;  (3) REF BH813R, Artery Forceps Curved 250MM;  (4) REF BJ016R, Diss.A.Ligat.Forceps S-Shaped CVD.210MM;  (5) REF BJ020R, Overholt-Geiss Suture FCPS #0CVD195MM;  (6) REF BJ021R, Overholt-Geiss Suture FCPS #1CVD205MM;  (7) REF BJ022R, Overholt-Geiss Suture FCPS #2CVD220MM;  (8) REF BJ023R, Overholt-Geiss Suture FCPS #3 CVD225MM;  (9) REF BJ025R, Overholt-Geiss Suture FCPS #5CVD230MM;  (10) REF BJ026R, Overholt-Geiss Suture FCPS #6 CVD225MM;  (11) REF BJ031R, Overholt-Geiss Suture FCPS#1CVD260MM;  (12) REF BJ034R, Overholt-Geiss Suture FCPS#4CVD270MM;  (13) REF BJ035R, Overholt-Geiss Suture FCPS #5CVD280MM;  (14) REF BJ037R, Forceps CVD Delicate 145MM;  (15) REF BJ038R, Forceps CVD.Delicate 185MM;  (16) REF BJ039R, Forceps CVD.Delicate 235MM;  (17) REF BJ041R, Rumel Suture Forceps SLT-CVD 240MM;  (18) REF BJ042R, Rumel Suture Forceps CVD 240MM;  (19) REF BJ043R, Rumel Suture Forceps MED-CV 240MM;  (20) REF BJ044R, Rumel Suture Forceps HVY-CV 240MM;  (21) REF BJ045R, Rumel Suture Forceps RT-ANG# 5 240MM;  (22) REF BJ047R, Zenker Suture Forceps SLT-CVD 300MM;  (23) REF BJ048R, Zenker Suture Forceps HVY-CVD 290MM;  (24) REF BJ050R, Mixter-O'Shaugnessy Forceps CVD190MM;  (25) REF BJ051R, Wikstroem Suture Forceps RT-ANG 205MM;  (26) REF BJ052R, Finochietto Suture FCPCVDW/HOLE245MM;  (27) REF BJ055R, Mixter Suture Forceps Rt-Ang 230MM;  (28) REF BJ057R, Kantrowitz Thoracic Clamp 200MM;  (29) REF BJ058R, Kantrowitz Thoracic Clamp 245MM;  (30) REF BJ059R, Kantrowitz Thoracic Clamp 275MM;  (31) REF BJ060R, Lahey Forceps Long-Serr 225MM;  (32) REF BJ061R, Mixter Forceps Long-Serr220MM;  (33) REF BJ062R, Mixter Forceps Long-Serr 250MM;  (34) REF BJ068R, Lahey DISS.A.LIGAT.FORCEPS 230MM;  (35) REF BJ070R, Lawrence Suture FCPS DEL CVDD 270MM;  (36) REF BJ073R, Mixter Forceps Long-Serr 290MM;  (37) REF BJ080R, Overholt Forceps # 0 CVD215MM;  (38) REF BJ081R, Overholt Forceps # 1 CVD210MM;  (39) REF BJ082R, Overholt Forceps # 2 CVD 220MM;  (40) REF BJ083R, Overholt Forceps # 3 CVD 225MM;  (41) REF BJ086R, Overholt Forceps # 6 CVD 225MM;  (42) REF BJ090R, Overholt Forceps # 0 CVD 295MM;  (43) REF BJ091R, Overholt Forceps # 1 CVD 295MM;  (44) REF BJ096R, Overholt Forceps # 6 CVD 300MM;  (45) REF BJ100R, Gemini Clamp RT-ANG140MM;  (46) REF BJ102R, Gemini Clamp RT-ANG 180MM;  (47) REF BJ103R, Gemini Clamp RT-ANG 200MM;  (48) REF BJ104R, Gemini Clamp RT-ANG 230MM;  (49) REF BJ106R, Gemini Clamp RT-ANG 280MM;  (50) REF BJ120R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 160MM;  (51) REF BJ121R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 180MM;  (52) REF BJ122R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 200MM;  (53) REF BJ123R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 220MM;  (54) REF BJ130R, Zenker DISS & LIG FCPSSLT-CVD 350MM;  (55) REF BJ131R, Zenker DISS & LIG FCPS CVD 350MM;  continued",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Aesculap Inc"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1310-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1310-2025: Aesculap Inc is recalling Numerous models of nonsterile hemostatic forceps:    (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM;  (2) REF BH304R, Pean Artery Forceps Straight 140MM;  (3) REF BH813R, Artery Forceps Curved 250MM;  (4) REF BJ016R, Diss.A.Ligat.Forceps S-Shaped CVD.210MM;  (5) REF BJ020R, Overholt-Geiss Suture FCPS #0CVD195MM;  (6) REF BJ021R, Overholt-Geiss Suture FCPS #1CVD205MM;  (7) REF BJ022R, Overholt-Geiss Suture FCPS #2CVD220MM;  (8) REF BJ023R, Overholt-Geiss Suture FCPS #3 CVD225MM;  (9) REF BJ025R, Overholt-Geiss Suture FCPS #5CVD230MM;  (10) REF BJ026R, Overholt-Geiss Suture FCPS #6 CVD225MM;  (11) REF BJ031R, Overholt-Geiss Suture FCPS#1CVD260MM;  (12) REF BJ034R, Overholt-Geiss Suture FCPS#4CVD270MM;  (13) REF BJ035R, Overholt-Geiss Suture FCPS #5CVD280MM;  (14) REF BJ037R, Forceps CVD Delicate 145MM;  (15) REF BJ038R, Forceps CVD.Delicate 185MM;  (16) REF BJ039R, Forceps CVD.Delicate 235MM;  (17) REF BJ041R, Rumel Suture Forceps SLT-CVD 240MM;  (18) REF BJ042R, Rumel Suture Forceps CVD 240MM;  (19) REF BJ043R, Rumel Suture Forceps MED-CV 240MM;  (20) REF BJ044R, Rumel Suture Forceps HVY-CV 240MM;  (21) REF BJ045R, Rumel Suture Forceps RT-ANG# 5 240MM;  (22) REF BJ047R, Zenker Suture Forceps SLT-CVD 300MM;  (23) REF BJ048R, Zenker Suture Forceps HVY-CVD 290MM;  (24) REF BJ050R, Mixter-O'Shaugnessy Forceps CVD190MM;  (25) REF BJ051R, Wikstroem Suture Forceps RT-ANG 205MM;  (26) REF BJ052R, Finochietto Suture FCPCVDW/HOLE245MM;  (27) REF BJ055R, Mixter Suture Forceps Rt-Ang 230MM;  (28) REF BJ057R, Kantrowitz Thoracic Clamp 200MM;  (29) REF BJ058R, Kantrowitz Thoracic Clamp 245MM;  (30) REF BJ059R, Kantrowitz Thoracic Clamp 275MM;  (31) REF BJ060R, Lahey Forceps Long-Serr 225MM;  (32) REF BJ061R, Mixter Forceps Long-Serr220MM;  (33) REF BJ062R, Mixter Forceps Long-Serr 250MM;  (34) REF BJ068R, Lahey DISS.A.LIGAT.FORCEPS 230MM;  (35) REF BJ070R, Lawrence Suture FCPS DEL CVDD 270MM;  (36) REF BJ073R, Mixter Forceps Long-Serr 290MM;  (37) REF BJ080R, Overholt Forceps # 0 CVD215MM;  (38) REF BJ081R, Overholt Forceps # 1 CVD210MM;  (39) REF BJ082R, Overholt Forceps # 2 CVD 220MM;  (40) REF BJ083R, Overholt Forceps # 3 CVD 225MM;  (41) REF BJ086R, Overholt Forceps # 6 CVD 225MM;  (42) REF BJ090R, Overholt Forceps # 0 CVD 295MM;  (43) REF BJ091R, Overholt Forceps # 1 CVD 295MM;  (44) REF BJ096R, Overholt Forceps # 6 CVD 300MM;  (45) REF BJ100R, Gemini Clamp RT-ANG140MM;  (46) REF BJ102R, Gemini Clamp RT-ANG 180MM;  (47) REF BJ103R, Gemini Clamp RT-ANG 200MM;  (48) REF BJ104R, Gemini Clamp RT-ANG 230MM;  (49) REF BJ106R, Gemini Clamp RT-ANG 280MM;  (50) REF BJ120R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 160MM;  (51) REF BJ121R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 180MM;  (52) REF BJ122R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 200MM;  (53) REF BJ123R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 220MM;  (54) REF BJ130R, Zenker DISS & LIG FCPSSLT-CVD 350MM;  (55) REF BJ131R, Zenker DISS & LIG FCPS CVD 350MM;  continued",
      "text": "The FDA logged enforcement record Z-1310-2025: Aesculap Inc is voluntarily recalling Numerous models of nonsterile hemostatic forceps:    (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM;  (2) REF BH304R, Pean Artery Forceps Straight 140MM;  (3) REF BH813R, Artery Forceps Curved 250MM;  (4) REF BJ016R, Diss.A.Ligat.Forceps S-Shaped CVD.210MM;  (5) REF BJ020R, Overholt-Geiss Suture FCPS #0CVD195MM;  (6) REF BJ021R, Overholt-Geiss Suture FCPS #1CVD205MM;  (7) REF BJ022R, Overholt-Geiss Suture FCPS #2CVD220MM;  (8) REF BJ023R, Overholt-Geiss Suture FCPS #3 CVD225MM;  (9) REF BJ025R, Overholt-Geiss Suture FCPS #5CVD230MM;  (10) REF BJ026R, Overholt-Geiss Suture FCPS #6 CVD225MM;  (11) REF BJ031R, Overholt-Geiss Suture FCPS#1CVD260MM;  (12) REF BJ034R, Overholt-Geiss Suture FCPS#4CVD270MM;  (13) REF BJ035R, Overholt-Geiss Suture FCPS #5CVD280MM;  (14) REF BJ037R, Forceps CVD Delicate 145MM;  (15) REF BJ038R, Forceps CVD.Delicate 185MM;  (16) REF BJ039R, Forceps CVD.Delicate 235MM;  (17) REF BJ041R, Rumel Suture Forceps SLT-CVD 240MM;  (18) REF BJ042R, Rumel Suture Forceps CVD 240MM;  (19) REF BJ043R, Rumel Suture Forceps MED-CV 240MM;  (20) REF BJ044R, Rumel Suture Forceps HVY-CV 240MM;  (21) REF BJ045R, Rumel Suture Forceps RT-ANG# 5 240MM;  (22) REF BJ047R, Zenker Suture Forceps SLT-CVD 300MM;  (23) REF BJ048R, Zenker Suture Forceps HVY-CVD 290MM;  (24) REF BJ050R, Mixter-O'Shaugnessy Forceps CVD190MM;  (25) REF BJ051R, Wikstroem Suture Forceps RT-ANG 205MM;  (26) REF BJ052R, Finochietto Suture FCPCVDW/HOLE245MM;  (27) REF BJ055R, Mixter Suture Forceps Rt-Ang 230MM;  (28) REF BJ057R, Kantrowitz Thoracic Clamp 200MM;  (29) REF BJ058R, Kantrowitz Thoracic Clamp 245MM;  (30) REF BJ059R, Kantrowitz Thoracic Clamp 275MM;  (31) REF BJ060R, Lahey Forceps Long-Serr 225MM;  (32) REF BJ061R, Mixter Forceps Long-Serr220MM;  (33) REF BJ062R, Mixter Forceps Long-Serr 250MM;  (34) REF BJ068R, Lahey DISS.A.LIGAT.FORCEPS 230MM;  (35) REF BJ070R, Lawrence Suture FCPS DEL CVDD 270MM;  (36) REF BJ073R, Mixter Forceps Long-Serr 290MM;  (37) REF BJ080R, Overholt Forceps # 0 CVD215MM;  (38) REF BJ081R, Overholt Forceps # 1 CVD210MM;  (39) REF BJ082R, Overholt Forceps # 2 CVD 220MM;  (40) REF BJ083R, Overholt Forceps # 3 CVD 225MM;  (41) REF BJ086R, Overholt Forceps # 6 CVD 225MM;  (42) REF BJ090R, Overholt Forceps # 0 CVD 295MM;  (43) REF BJ091R, Overholt Forceps # 1 CVD 295MM;  (44) REF BJ096R, Overholt Forceps # 6 CVD 300MM;  (45) REF BJ100R, Gemini Clamp RT-ANG140MM;  (46) REF BJ102R, Gemini Clamp RT-ANG 180MM;  (47) REF BJ103R, Gemini Clamp RT-ANG 200MM;  (48) REF BJ104R, Gemini Clamp RT-ANG 230MM;  (49) REF BJ106R, Gemini Clamp RT-ANG 280MM;  (50) REF BJ120R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 160MM;  (51) REF BJ121R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 180MM;  (52) REF BJ122R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 200MM;  (53) REF BJ123R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 220MM;  (54) REF BJ130R, Zenker DISS & LIG FCPSSLT-CVD 350MM;  (55) REF BJ131R, Zenker DISS & LIG FCPS CVD 350MM;  continued — reason: The forceps have been used in ways not covered by the design resulting in breakage of the clamps.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-01-31. Affected lots/codes: GTIN numbers:  (1) REF BH198R - 04038653026029; (2) REF BH304R - 04038653026333; (3) REF BH813R - 04038653026968; (4) REF BJ016R -  04038653027163; (5) REF BJ020R -  04038653027200; (6) REF BJ021R -  04038653027217; (7) REF BJ022R -  04038653027224; (8) REF BJ023R -  04038653027231; (9) REF BJ025R -  04038653027255; (10) REF BJ026R - 04038653027262; (11) REF BJ031R - 04038653027279; (12) REF BJ034R - 04038653027309; (13) REF BJ035R - 04038653027316; (14) REF BJ037R - 04046963458201; (15) REF BJ038R - 04046963458218; (16) REF BJ039R - 04046963458225; (17) REF BJ041R - 04038653027323; (18) REF BJ042R - 04038653027330; (19) REF BJ043R - 04038653027347; (20) REF BJ044R - 04038653027354; (21) REF BJ045R - 04038653027361; (22) REF BJ047R - 04038653027378; (23) REF BJ048R - 04038653027385; (24) REF BJ050R - 04038653139224; (25) REF BJ051R - 04038653027392; (26) REF BJ052R - 04038653139231; (27) REF BJ055R - 04038653027408; (28) REF BJ057R - 04038653139248; (29) REF BJ058R - 04038653139255; (30) REF BJ059R - 04038653139262; (31) REF BJ060R - 04038653139279; (32) REF BJ061R - 04038653027415; (33) REF BJ062R - 04038653027422; (34) REF BJ068R - 04038653027446; (35) REF BJ070R - 04038653139293; (36) REF BJ073R - 04046963365202; (37) REF BJ080R - 04038653027453; (38) REF BJ081R - 04038653027460; (39) REF BJ082R - 04038653027477; (40) REF BJ083R - 04038653027484; (41) REF BJ086R - 04038653027491; (42) REF BJ090R - 04038653027507; (43) REF BJ091R - 04038653027514; (44) REF BJ096R - 04038653027521; (45) REF BJ100R - 04038653027538; (46) REF BJ102R - 04038653027545; (47) REF BJ103R - 04038653027552; (48) REF BJ104R - 04038653027569; (49) REF BJ106R - 04038653027576; (50) REF BJ120R - 04038653027606; (51) REF BJ121R - 04038653027613; (52) REF BJ122R - 04038653027620; (53) REF BJ123R - 04038653027637; (54) REF BJ130R - 04038653256457; (55) REF BJ131R - 04038653256464; (56) REF BJ132R - 04038653256471; (57) REF FB440R - 04038653155897; (58) REF FB441R - 04038653155903; (59) REF FB442R - 04038653155910; (60) REF FB443R - 04038653155927; (61) REF FB446R - 04038653155958; (62) REF FB447R - 04038653155965; (63) REF FB448R - 04038653155972; (64) REF FB483R - 04038653156306; (65) REF FB486R - 04038653156337; (66) REF FB487R - 04038653156344; (67) REF FB496R - 04038653156436; (68) REF FB498R - 04038653156450; (69) REF FB499R - 04038653156467; (70) REF FB526R - 04038653156719; (71) REF FB527R - 04038653156726; (72) REF FB533R - 04038653156771; (73) REF FB534R - 04038653156788; (74) REF FB563R - 04038653156931; (75) REF FB570R - 04038653156979; (76) REF FB741R - 04038653157716; (77) REF FB961R - 04038653158560; (78) REF MD465R - 04038653379507; (79) REF MD466R - 04038653379521; (80) REF MD467R - 04038653379545; (81) REF MD468 - 04046963366117; (82) REF MD569 - 04046963365578; and (83) REF MD570R - 04038653394999.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1310-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1310-2025&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1310-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1310-2025 as Class II",
      "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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1310-2025&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1310-2025&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1310-2025/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1310-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1310-2025",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Aesculap Inc",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "The forceps have been used in ways not covered by the design resulting in breakage of the clamps.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-01-31",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "GTIN numbers:  (1) REF BH198R - 04038653026029; (2) REF BH304R - 04038653026333; (3) REF BH813R - 04038653026968; (4) REF BJ016R -  04038653027163; (5) REF BJ020R -  04038653027200; (6) REF BJ021R -  04038653027217; (7) REF BJ022R -  04038653027224; (8) REF BJ023R -  04038653027231; (9) REF BJ025R -  04038653027255; (10) REF BJ026R - 04038653027262; (11) REF BJ031R - 04038653027279; (12) REF BJ034R - 04038653027309; (13) REF BJ035R - 04038653027316; (14) REF BJ037R - 04046963458201; (15) REF BJ038R - 04046963458218; (16) REF BJ039R - 04046963458225; (17) REF BJ041R - 04038653027323; (18) REF BJ042R - 04038653027330; (19) REF BJ043R - 04038653027347; (20) REF BJ044R - 04038653027354; (21) REF BJ045R - 04038653027361; (22) REF BJ047R - 04038653027378; (23) REF BJ048R - 04038653027385; (24) REF BJ050R - 04038653139224; (25) REF BJ051R - 04038653027392; (26) REF BJ052R - 04038653139231; (27) REF BJ055R - 04038653027408; (28) REF BJ057R - 04038653139248; (29) REF BJ058R - 04038653139255; (30) REF BJ059R - 04038653139262; (31) REF BJ060R - 04038653139279; (32) REF BJ061R - 04038653027415; (33) REF BJ062R - 04038653027422; (34) REF BJ068R - 04038653027446; (35) REF BJ070R - 04038653139293; (36) REF BJ073R - 04046963365202; (37) REF BJ080R - 04038653027453; (38) REF BJ081R - 04038653027460; (39) REF BJ082R - 04038653027477; (40) REF BJ083R - 04038653027484; (41) REF BJ086R - 04038653027491; (42) REF BJ090R - 04038653027507; (43) REF BJ091R - 04038653027514; (44) REF BJ096R - 04038653027521; (45) REF BJ100R - 04038653027538; (46) REF BJ102R - 04038653027545; (47) REF BJ103R - 04038653027552; (48) REF BJ104R - 04038653027569; (49) REF BJ106R - 04038653027576; (50) REF BJ120R - 04038653027606; (51) REF BJ121R - 04038653027613; (52) REF BJ122R - 04038653027620; (53) REF BJ123R - 04038653027637; (54) REF BJ130R - 04038653256457; (55) REF BJ131R - 04038653256464; (56) REF BJ132R - 04038653256471; (57) REF FB440R - 04038653155897; (58) REF FB441R - 04038653155903; (59) REF FB442R - 04038653155910; (60) REF FB443R - 04038653155927; (61) REF FB446R - 04038653155958; (62) REF FB447R - 04038653155965; (63) REF FB448R - 04038653155972; (64) REF FB483R - 04038653156306; (65) REF FB486R - 04038653156337; (66) REF FB487R - 04038653156344; (67) REF FB496R - 04038653156436; (68) REF FB498R - 04038653156450; (69) REF FB499R - 04038653156467; (70) REF FB526R - 04038653156719; (71) REF FB527R - 04038653156726; (72) REF FB533R - 04038653156771; (73) REF FB534R - 04038653156788; (74) REF FB563R - 04038653156931; (75) REF FB570R - 04038653156979; (76) REF FB741R - 04038653157716; (77) REF FB961R - 04038653158560; (78) REF MD465R - 04038653379507; (79) REF MD466R - 04038653379521; (80) REF MD467R - 04038653379545; (81) REF MD468 - 04046963366117; (82) REF MD569 - 04046963365578; and (83) REF MD570R - 04038653394999.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Distribution was made nationwide and to PR.  There was also government/military distribution.    Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}