{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 5 } }, "results": [ { "cfres_id": "221459", "product_res_number": "Z-2918-2026", "event_date_initiated": "2026-06-24", "event_date_posted": "2026-08-07", "recall_status": "Open, Classified", "res_event_number": "99390", "product_code": "GAM", "k_numbers": [ "K100257" ], "product_description": "V-Loc 90 Absorbable Wound Closure Device\n\nVLOC 90 0 VL 22 GS-21\t\n\tVLOCM0336\n\t\nVLOC 90 0 VL 22 GS-25 VLOCM0436\t\n\tVLOCM0436\n\t\nVLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12\t\n\tVLOCM0003\n\t\nVLOCM0013 V-LOC* 90 4-0 CLR 30CM P12X12\t\n\tVLOCM0013\n\t\nVLOCM0024 V-LOC* 90 3-0 CLR 45CM P12X12\t\n\tVLOCM0024\n\nVLOCM0123 V-LOC* 90 4-0 CLR 45CM P14X12\t\n\tVLOCM0123\n\t\nVLOCM0315 V-LOC* 90 2-0 VIO 30CM GS21\t\n\tVLOCM0315\n\t\nVLOCM0603 V-LOC* 90 4-0 VIO 15CM V20X12\t\n\tVLOCM0603\n\t\nVLOCM0604 V-LOC* 90 3-0 VIO 15CM V20X12\t\n\tVLOCM0604\n\t\nVLOCM1203 V-LOC* 90 4-0 VIO 15CM CV15\t\n\tVLOCM1203\n\nVLOCM2115 V-LOC* 90 2-0 VIO 30CM GS22\t\n\tVLOCM2115", "code_info": "VLOCM0336\t\t\n\tUDI-DI 20884521132501\t\n\t\tLot A5M0917VY\n\t\t\nVLOCM0436\t\t\n\tUDI-DI 20884521827513\t\n\t\tLot A5M1035VY\n\t\t\nVLOCM0003\t\t\n\tUDI-DI 10884521131606\t\n\t\tLot A5M1022VFY\n\tUDI-DI 20884521131603\t\n\t\tLots A5M1022VFY\n\t\tA5M1166VFY\n\t\t\nVLOCM0013\t\t\n\tUDI-DI 10884521131644\t\n\t\tLot A5M1024VFY\n\tUDI-DI 20884521131641\t\n\t\tLots A5M1023VFY\n\t\tA5M1024VFY\n\t\t\nVLOCM0024\t\t\n\tUDI-DI 10884521131699\t\n\t\tLot A5M0860VFY\n\tUDI-DI 20884521131696\t\n\t\tLot A5M0860VFY\n\t\t\nVLOCM0123\t\t\n\tUDI-DI 20884521132235\t\n\t\tLot A5M1169VFY\n\t\t\nVLOCM0315\t\t\n\tUDI-DI 20884521132464\t\n\t\tLot A6A1005VY\n\t\t\nVLOCM0603\t\t\n\tUDI-DI 10884521132535\t\n\t\tLot A5M1246VY\n\tUDI-DI 20884521132532\t\n\t\tLot A5M1246VY\n\t\t\nVLOCM0604\t\t\n\tUDI-DI 10884521132542\t\n\t\tLot A5M1062VY\n\tUDI-DI 20884521132549\t\n\t\tLots A5M1014VY\n\t\tA5M1062VY\n\t\t\nVLOCM1203\t\t\n\tUDI-DI 10884521132757\t\n\t\tLot A6A1063VY\n\tUDI-DI 20884521132754\t\n\t\tLot A6A1063VY\n\t\t\nVLOCM2115\t\t\n\tUDI-DI 20884521133003\t\n\t\tLot A5M1155VY", "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 Technical Services\n800-255-6774", "reason_for_recall": "Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.", "root_cause_description": "Equipment maintenance", "action": "The firm began notifying consignees on 7/7/26 via email, mail, or electronically. Notices were titled, \"URGENT: VOLUNTARY MEDICAL DEVICE RECALL.\"\n\nCustomers were informed of the manufacturing nonconformance.\n\nIf products in scope of this field action have been used in patients under the customer's care, the customer is instructed to monitor for signs of infection or vision issues due to the possibility of biocontamination.\n\nCustomers were instructed to immediately identify, cease use, and quarantine all unused impacted product. Unused impacted product is to be returned to Medtronic.\n\nThe recall notice should be passed on to all those who need to be aware within the customer's organization or to any organization where devices have been transferred.", "product_quantity": "135,875 total", "distribution_pattern": "US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway, \nOman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, \nTaiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.", "openfda": { "k_number": [ "K153611", 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"3014276972", "1721676", "3010131137", "3003595343", "3032543753", "3045857302", "3006638824", "3000215273", "3013176080", "3003005156", "3004944585", "3014272734", "3044819802", "1614993", "3012101664", "3000268902", "3030446844", "3013644499", "3010862763", "1000219637", "2648623", "3002807111", "3011689956", "3035366890", "3009380063", "3002957101", "2210968", "3014479313", "3003300673", "3015207155", "1825034", "3004903580", "3004365956", "1000274611", "3038718579", "3004117249", "3002993297", "3010860245", "3005972890", "3003737899", "1000112877", "3015330532", "3011683674", "3018094310", "3018052045" ], "device_name": "Suture, Absorbable, Synthetic, Polyglycolic Acid", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4493", "device_class": "2" } } ] }