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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1309-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Numerous models of nonsterile hemostatic forceps:  (1) REF BH100R, Carrel Artery Forceps 85MM;  (2) REF BH104R, Hartmann Mosquito FCSDEL STR 100MM;  (3) REF BH105R, Hartmann Mosquito FCPSDELCVD100MM;  (4) REF BH108R, Micro-Halsted Forceps DEL STR125MM;  (5) REF BH109R, Micro-Halsted Forceps DEL CVM 125mm;  (6) REF BH114R, Hartmann Mosquito FCPSDELSTR1X2100MM;  (7) REF BH115R, Hartmann Mosquito FCPSDELCVD1X2100MM;  (8) REF BH118R, Micro-Halsted FCPS Del STR 1X2125MM;  (9) REF BH119R, Micro-Halsted FCPS Del CVD 1X2125MM;  (10) REF BH120R, Halsted-Mosquito FCPSDELSTR1X2125MM;  (11) REF BH121R, Halsted-Mosquito FCPS DELCVD1X2125MM;  (12) REF BH130R, Providence-Hosp FCPS Del STR140MM;  (13) REF BH131R, Providence-Hosp FCPS Del CVD 140MM;  (14) REF BH134R, Kelly Forceps Del STR 140MM;  (15) REF BH135R, Kelly Forceps Del CVM 140MM;  (16) REF BH139R, Dandy Delicate Forceps CVD140MM;  (17) REF BH140R, Baby Crile Forceps Del STR 140MM;  (18) REF BH141R, Baby Crile FORCEPSDELCVD140MM;  (19) REF BH143R, Dandy Del FCPS LAT-CVD 1X2 140MM;  (20) REF BH144R, Crile Forceps STR 140MM;  (21) REF BH145R, Crile Forceps CVD 140MM;  (22) REF BH150R, Baby Kocher Forceps STR 140MM;  (23) REF BH151R, Kocher Forceps Del CVD 1X2140MM;  (24) REF BH154R, Crile Forceps Del STR 1X2 140MM;  (25) REF BH155R, Crile Forceps Del CVD 1X2 140MM;  (26) REF BH160R, Leriche Delicate Forceps STR 150MM;  (27) REF BH161R, Leriche Delicate Forceps CVD 150MM;  (28) REF BH164R, Rankin FCPS Long Kelly Del STR160MM;  (29) REF BH166R, Crile Forceps STR 160MM;  (30) REF BH170R, Leriche Delicate Forceps STR 1X2150MM;  (31) REF BH171R, Leriche Delicate Forceps CVD1X2150MM;  (32) REF BH176R, Crile Forceps STR 1X2160MM;  (33) REF BH177R, Crile Forceps CVD 1X2 160MM;  (34) REF BH178R, Dixon-Lovelace Artery FCPS.1X2T.STR.160;  (35) REF BH197R, Birkett Delicate Forceps CVD185MM;  (36) REF BH199R, Nissen Delicate Forceps CVP 185MM;  (37) REF BH200R, Adson Delicate Forceps STR185MM;  (38) REF BH201R, Adson Delicate Forceps CVD 185MM;  (39) REF BH202R, Halsted Delicate Forceps STR 185MM;  (40) REF BH203R, Halsted Delicate Forceps CVD 185MM;  (41) REF BH205R, Adson Hemostatic FCPS CVD.215MM;  (42) REF BH206R, Heiss Delicate Forceps STR 200MM;  (43) REF BH207R, Heiss Delicate Forceps CVD 200MM;  (44) REF BH210R, Halsted-Mosquito Forceps DELSTR200MM;  (45) REF BH211R, Halsted-Mosquito FCPS Del CVD 200MM;  (46) REF BH212R, Halsted-Mosquito FCPSDELSTR1X2185MM;  (47) REF BH213R, Halsted-Mosquito FCPSDELCVD1X2185MM;  (48) REF BH214R, Halsted-Mosq.FCPSDELSTR1X2 200MM;  (49) REF BH215R, Halsted-Mosq.FCPSDELCVD 1X2 200MM;  (50) REF BH224R, Sarot Delicate Forceps 240MM;  (51) REF BH225R, Crafoord Delicate Forceps CVD 245MM;  (52) REF BH227R, Artery Forceps Crafoord MODIF.240MM;  (53) REF BH228R, Bengolea Delicate Forceps STR 245MM;  (54) REF BH229R, Bengolea Delicate Forceps CVD 245MM;  (55) REF BH230R, Bridge Delicate Forceps STR 275MM;  (56) REF BH231R, Bridge Delicate Forceps CVD 275MM;  (57) REF BH234R, Sarot Delicate Forceps STR 1X2240MM;  (58) REF BH316R, Pean Artery Forceps STR.165MM;  (59) REF BH332R, Spencer-Wells Forceps STR130MM;  (60) REF BH333R, Spencer-Wells Forceps CVD 130MM;  continued",
  "description": "FDA recall Z-1309-2025 — Aesculap Inc is recalling Numerous models of nonsterile hemostatic forceps:  (1) REF BH100R, Carrel Artery Forceps 85MM;  (2) REF BH104R, Hartmann Mosquito FCSDEL STR 100MM;  (3) REF BH105R, Hartmann Mosquito FCPSDELCVD100MM;  (4) REF BH108R, Micro-Halsted Forceps DEL STR125MM;  (5) REF BH109R, Micro-Halsted Forceps DEL CVM 125mm;  (6) REF BH114R, Hartmann Mosquito FCPSDELSTR1X2100MM;  (7) REF BH115R, Hartmann Mosquito FCPSDELCVD1X2100MM;  (8) REF BH118R, Micro-Halsted FCPS Del STR 1X2125MM;  (9) REF BH119R, Micro-Halsted FCPS Del CVD 1X2125MM;  (10) REF BH120R, Halsted-Mosquito FCPSDELSTR1X2125MM;  (11) REF BH121R, Halsted-Mosquito FCPS DELCVD1X2125MM;  (12) REF BH130R, Providence-Hosp FCPS Del STR140MM;  (13) REF BH131R, Providence-Hosp FCPS Del CVD 140MM;  (14) REF BH134R, Kelly Forceps Del STR 140MM;  (15) REF BH135R, Kelly Forceps Del CVM 140MM;  (16) REF BH139R, Dandy Delicate Forceps CVD140MM;  (17) REF BH140R, Baby Crile Forceps Del STR 140MM;  (18) REF BH141R, Baby Crile FORCEPSDELCVD140MM;  (19) REF BH143R, Dandy Del FCPS LAT-CVD 1X2 140MM;  (20) REF BH144R, Crile Forceps STR 140MM;  (21) REF BH145R, Crile Forceps CVD 140MM;  (22) REF BH150R, Baby Kocher Forceps STR 140MM;  (23) REF BH151R, Kocher Forceps Del CVD 1X2140MM;  (24) REF BH154R, Crile Forceps Del STR 1X2 140MM;  (25) REF BH155R, Crile Forceps Del CVD 1X2 140MM;  (26) REF BH160R, Leriche Delicate Forceps STR 150MM;  (27) REF BH161R, Leriche Delicate Forceps CVD 150MM;  (28) REF BH164R, Rankin FCPS Long Kelly Del STR160MM;  (29) REF BH166R, Crile Forceps STR 160MM;  (30) REF BH170R, Leriche Delicate Forceps STR 1X2150MM;  (31) REF BH171R, Leriche Delicate Forceps CVD1X2150MM;  (32) REF BH176R, Crile Forceps STR 1X2160MM;  (33) REF BH177R, Crile Forceps CVD 1X2 160MM;  (34) REF BH178R, Dixon-Lovelace Artery FCPS.1X2T.STR.160;  (35) REF BH197R, Birkett Delicate Forceps CVD185MM;  (36) REF BH199R, Nissen Delicate Forceps CVP 185MM;  (37) REF BH200R, Adson Delicate Forceps STR185MM;  (38) REF BH201R, Adson Delicate Forceps CVD 185MM;  (39) REF BH202R, Halsted Delicate Forceps STR 185MM;  (40) REF BH203R, Halsted Delicate Forceps CVD 185MM;  (41) REF BH205R, Adson Hemostatic FCPS CVD.215MM;  (42) REF BH206R, Heiss Delicate Forceps STR 200MM;  (43) REF BH207R, Heiss Delicate Forceps CVD 200MM;  (44) REF BH210R, Halsted-Mosquito Forceps DELSTR200MM;  (45) REF BH211R, Halsted-Mosquito FCPS Del CVD 200MM;  (46) REF BH212R, Halsted-Mosquito FCPSDELSTR1X2185MM;  (47) REF BH213R, Halsted-Mosquito FCPSDELCVD1X2185MM;  (48) REF BH214R, Halsted-Mosq.FCPSDELSTR1X2 200MM;  (49) REF BH215R, Halsted-Mosq.FCPSDELCVD 1X2 200MM;  (50) REF BH224R, Sarot Delicate Forceps 240MM;  (51) REF BH225R, Crafoord Delicate Forceps CVD 245MM;  (52) REF BH227R, Artery Forceps Crafoord MODIF.240MM;  (53) REF BH228R, Bengolea Delicate Forceps STR 245MM;  (54) REF BH229R, Bengolea Delicate Forceps CVD 245MM;  (55) REF BH230R, Bridge Delicate Forceps STR 275MM;  (56) REF BH231R, Bridge Delicate Forceps CVD 275MM;  (57) REF BH234R, Sarot Delicate Forceps STR 1X2240MM;  (58) REF BH316R, Pean Artery Forceps STR.165MM;  (59) REF BH332R, Spencer-Wells Forceps STR130MM;  (60) REF BH333R, Spencer-Wells Forceps CVD 130MM;  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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  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "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-1309-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Numerous models of nonsterile hemostatic forceps:  (1) REF BH100R, Carrel Artery Forceps 85MM;  (2) REF BH104R, Hartmann Mosquito FCSDEL STR 100MM;  (3) REF BH105R, Hartmann Mosquito FCPSDELCVD100MM;  (4) REF BH108R, Micro-Halsted Forceps DEL STR125MM;  (5) REF BH109R, Micro-Halsted Forceps DEL CVM 125mm;  (6) REF BH114R, Hartmann Mosquito FCPSDELSTR1X2100MM;  (7) REF BH115R, Hartmann Mosquito FCPSDELCVD1X2100MM;  (8) REF BH118R, Micro-Halsted FCPS Del STR 1X2125MM;  (9) REF BH119R, Micro-Halsted FCPS Del CVD 1X2125MM;  (10) REF BH120R, Halsted-Mosquito FCPSDELSTR1X2125MM;  (11) REF BH121R, Halsted-Mosquito FCPS DELCVD1X2125MM;  (12) REF BH130R, Providence-Hosp FCPS Del STR140MM;  (13) REF BH131R, Providence-Hosp FCPS Del CVD 140MM;  (14) REF BH134R, Kelly Forceps Del STR 140MM;  (15) REF BH135R, Kelly Forceps Del CVM 140MM;  (16) REF BH139R, Dandy Delicate Forceps CVD140MM;  (17) REF BH140R, Baby Crile Forceps Del STR 140MM;  (18) REF BH141R, Baby Crile FORCEPSDELCVD140MM;  (19) REF BH143R, Dandy Del FCPS LAT-CVD 1X2 140MM;  (20) REF BH144R, Crile Forceps STR 140MM;  (21) REF BH145R, Crile Forceps CVD 140MM;  (22) REF BH150R, Baby Kocher Forceps STR 140MM;  (23) REF BH151R, Kocher Forceps Del CVD 1X2140MM;  (24) REF BH154R, Crile Forceps Del STR 1X2 140MM;  (25) REF BH155R, Crile Forceps Del CVD 1X2 140MM;  (26) REF BH160R, Leriche Delicate Forceps STR 150MM;  (27) REF BH161R, Leriche Delicate Forceps CVD 150MM;  (28) REF BH164R, Rankin FCPS Long Kelly Del STR160MM;  (29) REF BH166R, Crile Forceps STR 160MM;  (30) REF BH170R, Leriche Delicate Forceps STR 1X2150MM;  (31) REF BH171R, Leriche Delicate Forceps CVD1X2150MM;  (32) REF BH176R, Crile Forceps STR 1X2160MM;  (33) REF BH177R, Crile Forceps CVD 1X2 160MM;  (34) REF BH178R, Dixon-Lovelace Artery FCPS.1X2T.STR.160;  (35) REF BH197R, Birkett Delicate Forceps CVD185MM;  (36) REF BH199R, Nissen Delicate Forceps CVP 185MM;  (37) REF BH200R, Adson Delicate Forceps STR185MM;  (38) REF BH201R, Adson Delicate Forceps CVD 185MM;  (39) REF BH202R, Halsted Delicate Forceps STR 185MM;  (40) REF BH203R, Halsted Delicate Forceps CVD 185MM;  (41) REF BH205R, Adson Hemostatic FCPS CVD.215MM;  (42) REF BH206R, Heiss Delicate Forceps STR 200MM;  (43) REF BH207R, Heiss Delicate Forceps CVD 200MM;  (44) REF BH210R, Halsted-Mosquito Forceps DELSTR200MM;  (45) REF BH211R, Halsted-Mosquito FCPS Del CVD 200MM;  (46) REF BH212R, Halsted-Mosquito FCPSDELSTR1X2185MM;  (47) REF BH213R, Halsted-Mosquito FCPSDELCVD1X2185MM;  (48) REF BH214R, Halsted-Mosq.FCPSDELSTR1X2 200MM;  (49) REF BH215R, Halsted-Mosq.FCPSDELCVD 1X2 200MM;  (50) REF BH224R, Sarot Delicate Forceps 240MM;  (51) REF BH225R, Crafoord Delicate Forceps CVD 245MM;  (52) REF BH227R, Artery Forceps Crafoord MODIF.240MM;  (53) REF BH228R, Bengolea Delicate Forceps STR 245MM;  (54) REF BH229R, Bengolea Delicate Forceps CVD 245MM;  (55) REF BH230R, Bridge Delicate Forceps STR 275MM;  (56) REF BH231R, Bridge Delicate Forceps CVD 275MM;  (57) REF BH234R, Sarot Delicate Forceps STR 1X2240MM;  (58) REF BH316R, Pean Artery Forceps STR.165MM;  (59) REF BH332R, Spencer-Wells Forceps STR130MM;  (60) REF BH333R, Spencer-Wells Forceps CVD 130MM;  continued",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Aesculap Inc"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1309-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1309-2025: Aesculap Inc is recalling Numerous models of nonsterile hemostatic forceps:  (1) REF BH100R, Carrel Artery Forceps 85MM;  (2) REF BH104R, Hartmann Mosquito FCSDEL STR 100MM;  (3) REF BH105R, Hartmann Mosquito FCPSDELCVD100MM;  (4) REF BH108R, Micro-Halsted Forceps DEL STR125MM;  (5) REF BH109R, Micro-Halsted Forceps DEL CVM 125mm;  (6) REF BH114R, Hartmann Mosquito FCPSDELSTR1X2100MM;  (7) REF BH115R, Hartmann Mosquito FCPSDELCVD1X2100MM;  (8) REF BH118R, Micro-Halsted FCPS Del STR 1X2125MM;  (9) REF BH119R, Micro-Halsted FCPS Del CVD 1X2125MM;  (10) REF BH120R, Halsted-Mosquito FCPSDELSTR1X2125MM;  (11) REF BH121R, Halsted-Mosquito FCPS DELCVD1X2125MM;  (12) REF BH130R, Providence-Hosp FCPS Del STR140MM;  (13) REF BH131R, Providence-Hosp FCPS Del CVD 140MM;  (14) REF BH134R, Kelly Forceps Del STR 140MM;  (15) REF BH135R, Kelly Forceps Del CVM 140MM;  (16) REF BH139R, Dandy Delicate Forceps CVD140MM;  (17) REF BH140R, Baby Crile Forceps Del STR 140MM;  (18) REF BH141R, Baby Crile FORCEPSDELCVD140MM;  (19) REF BH143R, Dandy Del FCPS LAT-CVD 1X2 140MM;  (20) REF BH144R, Crile Forceps STR 140MM;  (21) REF BH145R, Crile Forceps CVD 140MM;  (22) REF BH150R, Baby Kocher Forceps STR 140MM;  (23) REF BH151R, Kocher Forceps Del CVD 1X2140MM;  (24) REF BH154R, Crile Forceps Del STR 1X2 140MM;  (25) REF BH155R, Crile Forceps Del CVD 1X2 140MM;  (26) REF BH160R, Leriche Delicate Forceps STR 150MM;  (27) REF BH161R, Leriche Delicate Forceps CVD 150MM;  (28) REF BH164R, Rankin FCPS Long Kelly Del STR160MM;  (29) REF BH166R, Crile Forceps STR 160MM;  (30) REF BH170R, Leriche Delicate Forceps STR 1X2150MM;  (31) REF BH171R, Leriche Delicate Forceps CVD1X2150MM;  (32) REF BH176R, Crile Forceps STR 1X2160MM;  (33) REF BH177R, Crile Forceps CVD 1X2 160MM;  (34) REF BH178R, Dixon-Lovelace Artery FCPS.1X2T.STR.160;  (35) REF BH197R, Birkett Delicate Forceps CVD185MM;  (36) REF BH199R, Nissen Delicate Forceps CVP 185MM;  (37) REF BH200R, Adson Delicate Forceps STR185MM;  (38) REF BH201R, Adson Delicate Forceps CVD 185MM;  (39) REF BH202R, Halsted Delicate Forceps STR 185MM;  (40) REF BH203R, Halsted Delicate Forceps CVD 185MM;  (41) REF BH205R, Adson Hemostatic FCPS CVD.215MM;  (42) REF BH206R, Heiss Delicate Forceps STR 200MM;  (43) REF BH207R, Heiss Delicate Forceps CVD 200MM;  (44) REF BH210R, Halsted-Mosquito Forceps DELSTR200MM;  (45) REF BH211R, Halsted-Mosquito FCPS Del CVD 200MM;  (46) REF BH212R, Halsted-Mosquito FCPSDELSTR1X2185MM;  (47) REF BH213R, Halsted-Mosquito FCPSDELCVD1X2185MM;  (48) REF BH214R, Halsted-Mosq.FCPSDELSTR1X2 200MM;  (49) REF BH215R, Halsted-Mosq.FCPSDELCVD 1X2 200MM;  (50) REF BH224R, Sarot Delicate Forceps 240MM;  (51) REF BH225R, Crafoord Delicate Forceps CVD 245MM;  (52) REF BH227R, Artery Forceps Crafoord MODIF.240MM;  (53) REF BH228R, Bengolea Delicate Forceps STR 245MM;  (54) REF BH229R, Bengolea Delicate Forceps CVD 245MM;  (55) REF BH230R, Bridge Delicate Forceps STR 275MM;  (56) REF BH231R, Bridge Delicate Forceps CVD 275MM;  (57) REF BH234R, Sarot Delicate Forceps STR 1X2240MM;  (58) REF BH316R, Pean Artery Forceps STR.165MM;  (59) REF BH332R, Spencer-Wells Forceps STR130MM;  (60) REF BH333R, Spencer-Wells Forceps CVD 130MM;  continued",
      "text": "The FDA logged enforcement record Z-1309-2025: Aesculap Inc is voluntarily recalling Numerous models of nonsterile hemostatic forceps:  (1) REF BH100R, Carrel Artery Forceps 85MM;  (2) REF BH104R, Hartmann Mosquito FCSDEL STR 100MM;  (3) REF BH105R, Hartmann Mosquito FCPSDELCVD100MM;  (4) REF BH108R, Micro-Halsted Forceps DEL STR125MM;  (5) REF BH109R, Micro-Halsted Forceps DEL CVM 125mm;  (6) REF BH114R, Hartmann Mosquito FCPSDELSTR1X2100MM;  (7) REF BH115R, Hartmann Mosquito FCPSDELCVD1X2100MM;  (8) REF BH118R, Micro-Halsted FCPS Del STR 1X2125MM;  (9) REF BH119R, Micro-Halsted FCPS Del CVD 1X2125MM;  (10) REF BH120R, Halsted-Mosquito FCPSDELSTR1X2125MM;  (11) REF BH121R, Halsted-Mosquito FCPS DELCVD1X2125MM;  (12) REF BH130R, Providence-Hosp FCPS Del STR140MM;  (13) REF BH131R, Providence-Hosp FCPS Del CVD 140MM;  (14) REF BH134R, Kelly Forceps Del STR 140MM;  (15) REF BH135R, Kelly Forceps Del CVM 140MM;  (16) REF BH139R, Dandy Delicate Forceps CVD140MM;  (17) REF BH140R, Baby Crile Forceps Del STR 140MM;  (18) REF BH141R, Baby Crile FORCEPSDELCVD140MM;  (19) REF BH143R, Dandy Del FCPS LAT-CVD 1X2 140MM;  (20) REF BH144R, Crile Forceps STR 140MM;  (21) REF BH145R, Crile Forceps CVD 140MM;  (22) REF BH150R, Baby Kocher Forceps STR 140MM;  (23) REF BH151R, Kocher Forceps Del CVD 1X2140MM;  (24) REF BH154R, Crile Forceps Del STR 1X2 140MM;  (25) REF BH155R, Crile Forceps Del CVD 1X2 140MM;  (26) REF BH160R, Leriche Delicate Forceps STR 150MM;  (27) REF BH161R, Leriche Delicate Forceps CVD 150MM;  (28) REF BH164R, Rankin FCPS Long Kelly Del STR160MM;  (29) REF BH166R, Crile Forceps STR 160MM;  (30) REF BH170R, Leriche Delicate Forceps STR 1X2150MM;  (31) REF BH171R, Leriche Delicate Forceps CVD1X2150MM;  (32) REF BH176R, Crile Forceps STR 1X2160MM;  (33) REF BH177R, Crile Forceps CVD 1X2 160MM;  (34) REF BH178R, Dixon-Lovelace Artery FCPS.1X2T.STR.160;  (35) REF BH197R, Birkett Delicate Forceps CVD185MM;  (36) REF BH199R, Nissen Delicate Forceps CVP 185MM;  (37) REF BH200R, Adson Delicate Forceps STR185MM;  (38) REF BH201R, Adson Delicate Forceps CVD 185MM;  (39) REF BH202R, Halsted Delicate Forceps STR 185MM;  (40) REF BH203R, Halsted Delicate Forceps CVD 185MM;  (41) REF BH205R, Adson Hemostatic FCPS CVD.215MM;  (42) REF BH206R, Heiss Delicate Forceps STR 200MM;  (43) REF BH207R, Heiss Delicate Forceps CVD 200MM;  (44) REF BH210R, Halsted-Mosquito Forceps DELSTR200MM;  (45) REF BH211R, Halsted-Mosquito FCPS Del CVD 200MM;  (46) REF BH212R, Halsted-Mosquito FCPSDELSTR1X2185MM;  (47) REF BH213R, Halsted-Mosquito FCPSDELCVD1X2185MM;  (48) REF BH214R, Halsted-Mosq.FCPSDELSTR1X2 200MM;  (49) REF BH215R, Halsted-Mosq.FCPSDELCVD 1X2 200MM;  (50) REF BH224R, Sarot Delicate Forceps 240MM;  (51) REF BH225R, Crafoord Delicate Forceps CVD 245MM;  (52) REF BH227R, Artery Forceps Crafoord MODIF.240MM;  (53) REF BH228R, Bengolea Delicate Forceps STR 245MM;  (54) REF BH229R, Bengolea Delicate Forceps CVD 245MM;  (55) REF BH230R, Bridge Delicate Forceps STR 275MM;  (56) REF BH231R, Bridge Delicate Forceps CVD 275MM;  (57) REF BH234R, Sarot Delicate Forceps STR 1X2240MM;  (58) REF BH316R, Pean Artery Forceps STR.165MM;  (59) REF BH332R, Spencer-Wells Forceps STR130MM;  (60) REF BH333R, Spencer-Wells Forceps CVD 130MM;  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) BH100R - 04038653139064; (2) BH104R - 04038653025558; (3)BH105R -  04038653025565; (4) BH108R - 04038653025572; (5) BH109R - 04038653025589; (6) BH114R - 04038653025619; (7) BH115R - 04038653025626; (8) BH118R - 04038653025633; (9) BH119R - 04038653025640; (10) BH120R - 04038653025657; (11) BH121R - 04038653025664; (12) BH130R - 04038653025725; (13) BH131R - 04038653025732; (14) BH134R - 04038653025749; (15) BH135R - 04038653025756; (16) BH139R - 04038653025763; (17) BH140R - 04038653025770; (18) BH141R - 04038653025787; (19) BH143R - 04038653139088; (20) BH144R - 04038653025794; (21) BH145R - 04038653025800; (22) BH150R - 04038653025817; (23) BH151R - 04038653025824; (24) BH154R - 04038653025831; (25) BH155R - 04038653025848; (26) BH160R - 04038653025855; (27) BH161R - 04038653025862; (28) BH164R - 04038653025879; (29) BH166R - 04038653025893; (30) BH170R - 04038653025923; (31) BH171R - 04038653025930; (32) BH176R - 04038653025947; (33) BH177R - 04038653025954; (34) BH178R - 04038653025961; (35) BH197R - 04038653026012; (36) BH199R - 04038653026036; (37) BH200R - 04038653026043; (38) BH201R - 04038653026050; (39) BH202R - 04038653026067; (40) BH203R - 04038653026074; (41) BH205R - 04038653411542; (42) BH206R - 04038653026081; (43) BH207R - 04038653026098; (44) BH210R - 04038653026111; (45) BH211R - 04038653026128; (46) BH212R - 04038653026135; (47) BH213R - 04038653026142; (48) BH214R - 04038653026159; (49) BH215R - 04038653026166; (50) BH224R - 04038653026203; (51) BH225R - 04038653026210; (52) BH227R - 04038653026227; (53) BH228R - 04038653026234; (54) BH229R - 04038653026241; (55) BH230R - 04038653026258; (56) BH231R - 04038653026265; (57) BH234R - 04038653026272; (58) BH316R - 04038653026357; (59) BH332R - 04038653026371; (60) BH333R - 04038653026388; (61) BH334R - 04038653026395; (62) BH335R - 04038653026401; (63) BH336R - 04038653026418; (64) BH337R - 04038653026425; (65) BH339R - 04038653026449; (66) BH410R - 04038653139101; (67) BH412R - 04038653026487; (68) BH413R - 04038653026494; (69) BH414R - 04038653026500; (70) BH415R - 04038653026517; (71) BH422R - 04038653026524; (72) BH424R - 04038653026531; (73) BH425R - 04038653026548; (74) BH442R - 04038653026555; (75) BH443R - 04038653026562; (76) BH444R - 04038653026579; (77) BH445R - 04038653026586; (78) BH446R - 04038653026593; (79) BH447R - 04038653026609; (80) BH448R - 04038653026616; (81) BH449R - 04038653026623; (82) BH450R - 04038653026630; (83) BH451R - 04038653026647; (84) BH456R - 04046963068783; (85) BH470R - 04038653026654; (86) BH471R - 04038653026661; (87) BH472R - 04038653026678; (88) BH473R - 04038653026685; (89) BH474R - 04038653026692; (90) BH612R - 04038653026722; (91) BH614R - 04038653026739; (92) BH615R - 04038653026746; (93) BH618R - 04038653026753; (94) BH619R - 04038653026760; (95) BH630R - 04038653026777; (96) BH631R - 04038653026784; (97) BH642R - 04038653026791; (98) BH643R - 04038653026807; (99) BH644R - 04038653026814; (100) BH645R - 04038653026821; (101) BH646R - 04038653026838; (102) BH647R - 04038653026845; (103) BH648R - 04038653026852; (104) BH649R - 04038653026869; (105) BH650R - 04038653026876; (106) BH651R - 04038653026883; (107) BH652R - 04038653026890; (108) BH653R - 04038653026906; (109) BH654R - 04038653026913; (110) BH655R - 04038653026920; (111) BH800R - 04038653139118; (112) BH801R - 04038653139125; (113) BH804R - 04038653139132; (114) BH805R - 04038653139149; (115) BH812R - 04038653026951; (116) BH831R - 04038653026982; (117) BH833R - 04038653026999; (118) MB229R - 04046963364458; and (119) MD469 - 04046963366148.. 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-1309-2025&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-1309-2025&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-1309-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1309-2025 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-1309-2025&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-1309-2025&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-1309-2025/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-1309-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1309-2025",
            "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) BH100R - 04038653139064; (2) BH104R - 04038653025558; (3)BH105R -  04038653025565; (4) BH108R - 04038653025572; (5) BH109R - 04038653025589; (6) BH114R - 04038653025619; (7) BH115R - 04038653025626; (8) BH118R - 04038653025633; (9) BH119R - 04038653025640; (10) BH120R - 04038653025657; (11) BH121R - 04038653025664; (12) BH130R - 04038653025725; (13) BH131R - 04038653025732; (14) BH134R - 04038653025749; (15) BH135R - 04038653025756; (16) BH139R - 04038653025763; (17) BH140R - 04038653025770; (18) BH141R - 04038653025787; (19) BH143R - 04038653139088; (20) BH144R - 04038653025794; (21) BH145R - 04038653025800; (22) BH150R - 04038653025817; (23) BH151R - 04038653025824; (24) BH154R - 04038653025831; (25) BH155R - 04038653025848; (26) BH160R - 04038653025855; (27) BH161R - 04038653025862; (28) BH164R - 04038653025879; (29) BH166R - 04038653025893; (30) BH170R - 04038653025923; (31) BH171R - 04038653025930; (32) BH176R - 04038653025947; (33) BH177R - 04038653025954; (34) BH178R - 04038653025961; (35) BH197R - 04038653026012; (36) BH199R - 04038653026036; (37) BH200R - 04038653026043; (38) BH201R - 04038653026050; (39) BH202R - 04038653026067; (40) BH203R - 04038653026074; (41) BH205R - 04038653411542; (42) BH206R - 04038653026081; (43) BH207R - 04038653026098; (44) BH210R - 04038653026111; (45) BH211R - 04038653026128; (46) BH212R - 04038653026135; (47) BH213R - 04038653026142; (48) BH214R - 04038653026159; (49) BH215R - 04038653026166; (50) BH224R - 04038653026203; (51) BH225R - 04038653026210; (52) BH227R - 04038653026227; (53) BH228R - 04038653026234; (54) BH229R - 04038653026241; (55) BH230R - 04038653026258; (56) BH231R - 04038653026265; (57) BH234R - 04038653026272; (58) BH316R - 04038653026357; (59) BH332R - 04038653026371; (60) BH333R - 04038653026388; (61) BH334R - 04038653026395; (62) BH335R - 04038653026401; (63) BH336R - 04038653026418; (64) BH337R - 04038653026425; (65) BH339R - 04038653026449; (66) BH410R - 04038653139101; (67) BH412R - 04038653026487; (68) BH413R - 04038653026494; (69) BH414R - 04038653026500; (70) BH415R - 04038653026517; (71) BH422R - 04038653026524; (72) BH424R - 04038653026531; (73) BH425R - 04038653026548; (74) BH442R - 04038653026555; (75) BH443R - 04038653026562; (76) BH444R - 04038653026579; (77) BH445R - 04038653026586; (78) BH446R - 04038653026593; (79) BH447R - 04038653026609; (80) BH448R - 04038653026616; (81) BH449R - 04038653026623; (82) BH450R - 04038653026630; (83) BH451R - 04038653026647; (84) BH456R - 04046963068783; (85) BH470R - 04038653026654; (86) BH471R - 04038653026661; (87) BH472R - 04038653026678; (88) BH473R - 04038653026685; (89) BH474R - 04038653026692; (90) BH612R - 04038653026722; (91) BH614R - 04038653026739; (92) BH615R - 04038653026746; (93) BH618R - 04038653026753; (94) BH619R - 04038653026760; (95) BH630R - 04038653026777; (96) BH631R - 04038653026784; (97) BH642R - 04038653026791; (98) BH643R - 04038653026807; (99) BH644R - 04038653026814; (100) BH645R - 04038653026821; (101) BH646R - 04038653026838; (102) BH647R - 04038653026845; (103) BH648R - 04038653026852; (104) BH649R - 04038653026869; (105) BH650R - 04038653026876; (106) BH651R - 04038653026883; (107) BH652R - 04038653026890; (108) BH653R - 04038653026906; (109) BH654R - 04038653026913; (110) BH655R - 04038653026920; (111) BH800R - 04038653139118; (112) BH801R - 04038653139125; (113) BH804R - 04038653139132; (114) BH805R - 04038653139149; (115) BH812R - 04038653026951; (116) BH831R - 04038653026982; (117) BH833R - 04038653026999; (118) MB229R - 04046963364458; and (119) MD469 - 04046963366148.",
            "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"
          }
        }
      ]
    }
  ]
}