{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196152", "product_res_number": "Z-0200-2023", "event_date_initiated": "2022-09-28", "event_date_posted": "2022-11-11", "recall_status": "Open, Classified", "res_event_number": "90892", "product_code": "GAM", "k_numbers": [ "K111442" ], "product_description": "Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device.", "code_info": "Model VLOCA004L\nUDI-DI: 20884521068084\nLots\nN1G0268Y\nN9M0756Y\n\nModel VLOCA006L\nUDI-DI: 20884521068091\nLots\nN0D0586Y\nN0H0178Y\nN1A0817Y\nN1B0531Y\nN1E0104Y\nN1E0747Y\nN1F0714Y\nN1H0583Y\nN1J0848Y\nN2D0068Y\nN2D0077Y\nN2D0240Y\n\nModel VLOCA008L\nUDI-DI: 20884521068275\nLots\nN0A0577Y\nN0C0316Y\nN0D0001Y\nN0D0106Y\nN0D0397Y\nN0D0398Y\nN0E0682Y\nN0F0368Y\nN0F0758Y\nN0F0969Y\nN0G0972Y\nN0J1022Y\nN0J1023Y\nN0K0723Y\nN0K1031Y\nN0L0127Y\nN0L0128Y\nN0M0360Y\nN0M0513Y\nN1A0199Y\nN1A0660Y\nN1A0816Y\nN1A0958Y\nN1B0110Y\nN1B0750Y\nN1C0088Y\nN1C0398Y\nN1C0495Y\nN1D0528Y\nN1D0697Y\nN1D0853Y\nN1E0102Y\nN1E0103Y\nN1F0035Y\nN1F0182Y\nN1G0107Y\nN1G0404Y\nN1G0628Y\nN1H0234Y\nN1H0677Y\nN1J0440Y\nN1K0248Y\nN1K0306Y\nN1K0867Y\nN1L0592Y\nN1L0766Y\nN1M0720Y\nN1M0731Y\nN2A0468Y\nN2B0095Y\nN2B0188Y\nN2B0289Y\nN2C0008Y\nN2C0009Y\nN2C0032Y\nN2C0495Y\nN2C0683Y\nN2D0813Y\nN2D0814Y\nN9K1167Y\nN9K1169Y\nN9L0102Y\nN9L0103Y\nN9L0503Y\nN9L0966Y\nN9M0077Y\n\nModel VLOCA204L\nUDI-DI: 20884521068114\nLots\nN0C0212Y\nN0J0294Y\n\nModel VLOCA206L\nUDI-DI: 20884521068121\nLots\nN0C0307Y\nN0D0105Y\nN0D0326Y\nN0D0327Y\nN0D0587Y\nN0E0718Y\nN0E0979Y\nN1A0502Y\nN1E0748Y\nN1F0701Y\nN1F0915Y\nN1G0759Y\nN1H0058Y\nN1H0803Y\nN1K0185Y\nN1M0276Y\nN2C0524Y\nN2D0233Y\nN2D0444Y\nN2D0445Y\n\nModel VLOCA208L\nUDI-DI: 20884521068282\nLots N0A0201Y\nN0C1103Y\nN0D0498Y\nN0D0506Y\nN0F0759Y\nN0G0279Y\nN0G0280Y\nN0H0960Y\nN0K0671Y\nN0K0672Y\nN0M0315Y\nN0M0393Y\nN1A0156Y\nN1A0501Y\nN1B0084Y\nN1B0263Y\nN1B0560Y\nN1C0728Y\nN1E0462Y\nN1E0508Y\nN1F0048Y\nN1F0556Y\nN1G0123Y\nN1G0442Y\nN1H0056Y\nN1H0257Y\nN1H0666Y\nN1H0901Y\nN1J0216Y\nN1J0510Y\nN1J0850Y\nN1K0164Y\nN1L0069Y\nN1L0494Y\nN1L0672Y\nN2A0110Y\nN2B0148Y\nN2E0299Y\nN9K1182Y\nN9L0093Y\nN9L0502Y\nN9L0737Y\nN9L0738Y\nN9L0761Y\nN9M0758Y\n\nModel VLOCA304L\nUDI-DI: 20884521068138\nLots\nN0B0409Y\nN0D0405Y\nN0F1041Y\nN0J0293Y\n\nModel VLOCA306L\nUDI-DI: 20884521068152\nLots\nN0A0239Y\nN0A0527Y\nN0F0833Y\nN0H1087Y\nN1F0811Y\nN1G0287Y\nN1G0763Y\nN1K0247Y\nN2B0322Y\nN2C0682Y\nN2D0302Y\nN2D0552Y\nN9J0258Y\nN9M0757Y\n\nModel VLOCA308L\nUDI-DI: 20884521068787\nLots\nN0A0383Y\nN0K0988Y\nN1G0106Y\nN1G0551Y\nN1L0085Y\nN1L0162Y\nN2C0509Y", "firm_fei_number": "1219930", "recalling_firm": "Covidien, LP", "address_1": "60 Middletown Ave", "city": "North Haven", "state": "CT", "postal_code": "06473-3908", "additional_info_contact": "Medtronic Customer Service\n800-962-9888", "reason_for_recall": "Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and unintended radiation exposure from additional imaging for both intra-op and postoperative scenarios.", "root_cause_description": "Process control", "action": "Beginning 28-September-2022 communications to all affected consignees\nbegan.\nConsignees are asked to return any affected product they may have,\nforward this notification to those who need to be aware within the\norganization and to any location which the devices have been transferred.\nConsignees are asked to complete and return a confirmation certificate (or\nequivalent record) confirming they have received the notification.", "product_quantity": "117978", "distribution_pattern": "Domestic distribution nationwide.\n\nForeign distribution to Australia\nAustria\nBelgium\nCanada\nCanary Islands\nChile\nCroatia\nCyprus\nDenmark\nEgypt\nFinland\nFrance\nGermany\nGreece\nHungary\nIreland\nIsrael\nItaly\nJordan\nKazakhstan\nKuwait\nLithuania\nLuxembourg\nMexico\nNetherlands\nNew Zealand\nNorway\nPoland\nPortugal\nPuerto Rico\nQatar\nReunion\nRomania\nRussian Federation\nSaudi Arabia\nSlovakia\nSouth Africa\nSpain\nSweden\nSwitzerland\nTurkey\nUnited Arab Emirates\nUnited Kingdom", "openfda": { "k_number": [ "K200392", "K930588", "K161726", "K052437", "K003017", "K252820", "K141625", "K132580", "K171001", "K905482", "K122734", "K021767", "K994001", "K041806", "K211792", "K962480", "K014021", "K951520", "K050771", "K082662", "K033762", "K062366", "K051415", "K930360", "K091087", "K061796", "K000037", "K102592", "K170166", "K093408", "K042141", "K173874", "K201996", "K953869", "K143584", "K072646", "K930772", "K040477", "K002190", "K965162", "K060801", "K171494", "K140039", "K072028", "K160564", "K232372", "K944110", "K140227", "K180625", "K010672", "K032586", "K043539", "K946271", "K042233", "K111442", "K060828", "K980704", "K163676", "K212810", "K032420", "K051700", "K161629", "K170661", "K253620", "K033746", "K040282", "K022664", "K053636", "K002639", "K122898", "K022269", "K080412", "K181320", "K032698", "K120556", "K183004", "K031286", "K072859", "K130735", "K011375", "K930746", "K013177", "K072229", "K130083", "K011372", "K984374", "K081002", "K041515", "K142061", "K963253", "K183183", "K202950", "K073493", "K023710", "K100257", "K990432", "K173043", "K072645", "K183001", "K123940", "K141558", "K142822", "K033115", "K013671", "K151200", "K042288", "K172659", "K944937", "K072644", "K981935", "K150717", "K221744", "K970863", "K200140", "K050845", "K974299", "K123409", "K050611", "K253852", "K072863", "K253394", "K972566", "K153611", "K022715", "K130737", "K991191", "K961997", "K964345", "K990951", "K233265", "K992088", "K970317", "K063462", "K142810", "K181652", "K980610", "K915835", "K141778", "K123836", "K221527", "K253530", "K173779", "K945285", "K081003", "K063536", "K951352", "K252743", "K192580", "K971208" ], "pma_number": [ "N18387", "N16881", "P840051" ], "registration_number": [ "3013403214", "3010860245", "3015453963", "2210968", "3013644499", "1058584", "3013298431", "3003418325", "1531174", "3014479313", "3014592276", "3010419931", "3011803381", "1423662", "3015542154", "3008114965", "9710098", "1825034", "9611459", "2125050", "3008912461", "3017196117", "2648623", "2650143", "3004215117", "2183301", "3015330532", "3007009755", "3044819802", "3002692886", "3005972890", "3010864832", "3029901632", "9612501", "3019924", "3014276972", "3014615644", "1720929", "3018094310", "3015489699", "3008879776", "3018052045", "3045857302", "3043226252", "3010692967", "3004111573", "3043225236", "3004431266", "3004365956", "3017102971", "1319660", "3014272734", "3005953126", "1000274611", "3014461810", "9681572", "9616088", "3008868758", "1037089", "3003595343", "3007006186", "1018470", "3010041511", "3006680097", "3011085362", "1221601", "3003639970", "1219930", "3005941719", "3010452421", "2648650", "3030733800", "3011276344", "1221934", "3012494290", "3012421607", "3004117249", "3001124136", "1320468", "3007205024", "3011683674", "1423537", "1043214", "1721676", "2020601", "3045857207", "3010131137", "3004192065", "3038718579", "3013187142", "1066741", "3045855232", "3027448274", "1061124", "3013557562", "3004944585", "3032543753", "3003828812", "3012502601", "3006638824", "3006562124", "2245304", "3013188547", "1055236", "1614993", "1064584", "1036836", "9617547", "2521877", "3016904853", "3007791573", "3012101664", "3003267729", "3006981798", "3011689956", "3014273254", "3013548553", "3007791599", "3004845555", "2246552", "3024021261", "3000268902", "2183744", "1319639", "3003300673", "3002294946", "3013176080", "3035366890", "3004060107", "3030446844", "1064514", "2030624", "1054241", "9680794", "3011137372", "2320762", "3006425876", "3004903580", "3009968482", "3009380063", "2528981", "3015207155", "3014579161", "3018064853", "3020983460", "3014279513" ], "fei_number": [ "3013403214", "3010860245", "3015453963", "1000138054", "2210968", "3002902735", "1000219637", "3005747797", "3013644499", "3002957101", "3001236905", "3003263857", "3013298431", "3003418325", "3014479313", "3014592276", "3010419931", "3011803381", "3003040625", "2648209", "3015542154", "3008114965", "1825034", "2125050", "3008912461", "3000206435", "3017196117", "2648623", "3004215117", "2183301", "3000206455", "3015330532", "3007009755", "3044819802", "3002807111", "3002692886", "3005972890", "3029901632", "3019924", "3014276972", "3014615644", "1720929", "3018094310", "3015489699", "3008879776", "3003063934", "3018052045", "3045857302", "3043226252", "3010692967", "3004111573", "3043225236", "3004161528", "3004431266", "3004365956", "3017102971", "3014272734", "3005953126", "1000274611", "3014461810", "3008868758", "1037089", "3003595343", "3007006186", "1018470", "3010041511", "3006680097", "3011085362", "1221601", "1000136478", "3003639970", "1219930", "3010452421", "2648650", "3030733800", "3003495548", "3002993297", "3011276344", "1221934", "3012494290", "3012421607", "3002807993", "3004117249", "3001124136", "3007205024", "3011683674", "1043214", "1000112968", "1721676", "2020601", "3045857207", "3010131137", "3004192065", "3038718579", "3013187142", "1000512168", "3003737899", "3045855232", "3000215273", "3003005156", "3027448274", "3013557562", "3004944585", "3032543753", "3003828812", "3012502601", "3010862763", "3006638824", "3006562124", "2245304", "3013188547", "1000112877", "3003272809", "1614993", "1036836", "2521877", "3016904853", "3007791573", "3012101664", "3003267729", "3006981798", "3011689956", "3014273254", "3013548553", "3007791599", "3004845555", "2246552", "3024021261", "3000268902", "2183744", "3003300673", "3002294946", "3013176080", "3035366890", "3004060107", "3030446844", "3006425876", "3004903580", "3009968482", "3009380063", "2528981", "3015207155", "3014579161", "3018064853", "3020983460", "3014279513" ], "device_name": "Suture, Absorbable, Synthetic, Polyglycolic Acid", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4493", "device_class": "2" } } ] }