{ "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": "2026-08-19", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Ongoing", "city": "North Haven", "state": "CT", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "99390", "recalling_firm": "Covidien, LP", "address_1": "60 Middletown Ave", "address_2": "", "postal_code": "06473-3908", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "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, Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.", "recall_number": "Z-2919-2026", "product_description": "V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING\t \tBOX06614V4 \t BOX BY PASS FINAL\t \tBOX07405V1 \t BOX BYPASS CARDON\t \tBOX01056V2\t \t BOX BYPASS DR LAGAE\t \tBOX01482V2 \t\t BOX BYPASS KIT DEZEMBER 2025\t \tBOX09222V1 \t\t BOX BYPASS KIT NEU BOX 003\t \tBOX08767V1 \t BOX GASTRIC BYPASS\t \tJAWBYPASS2 \t BOX GASTRIC BYPASS SIGNIA\t \tBOX02191V11 BOX GASTRICBYPASS KIT V4\t \tBOX06863V4 \t BOX GB BOX MET LHOOK\t \tPST04884V3 BOX GB ZONDER ENDOHERNIA EGIA\t \tPST04884V6 BOX GBP SIGNIA\t \tBOX08506V2 BOX KIT COLON IHS\t \tKIT00625V1\t \t BOX KIT HERNIA HIATO IHS\t \tKIT01026V1\t \t BOX LAP HERNIE INGUNIAL RIGHT\t \tBOX00051V4 BOX NEW GBP KIT\t \tPST03130V2 BOX ZESTAW DO BARIATRII GB\t \tUCKGB5 BOX ZESTAW DO RYGB\t \tWEJRYGB3 VLOCL0013 V-LOC* 180 4-0 CLR 30CM P12\t \tVLOCL0013 VLOCL0014 V-LOC* 180 3-0 CLR 30CM P12\t \tVLOCL0014 VLOCL0023 V-LOC* 180 4-0 CLR 45CM P12\t \tVLOCL0023 VLOCL0024 V-LOC* 180 3-0 CLR 45CM P12\t \tVLOCL0024 VLOCL0306 V-LOC 180 DEVICE 0 15CM GS-21\t \tVLOCL0306 VLOCL0316 V-LOC* 180 0 GRN 30CM GS21X12\t \tVLOCL0316 \t VLOCL0345 V-LOC* 180 2-0 GRN 23CM GS21\t \tVLOCL0345 VLOCL0436 V-LOC* 180 0 GRN 60CM GS25X12\t \tVLOCL0436 VLOCL0604 V-LOC* 180 3-0 GRN 15CM V20\t \tVLOCL0604 VLOCL0615 V-LOC* 180 2-0 GRN 30CM V20\t \tVLOCL0615 \t VLOCL0625 V-LOC* 180 2-0 GRN 45CM V20\t \tVLOCL0625 \t VLOCL0644 V-LOC* 180 3-0 GRN 23CM V20\t \tVLOCL0644 \t VLOCL0804 V-LOC 180 3-0 GRN 15CM CV23\t \tVLOCL0804 VLOCL2105 V-LOC* 180 2-0 GRN 15CM GS22\t \tVLOCL2105 VLOCL2145 V-LOC* 180 2-0 GRN 23CM GS22\t \tVLOCL2145 VLOCL2246 VLOC180 0 GRN 9 GS-22\t \tVLOCL2246", "product_quantity": "135,875 total", "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.", "recall_initiation_date": "20260624", "center_classification_date": "20260807", "report_date": "20260819", "code_info": "BOX06614V4 UDI-DI 00199150037902 Lots 0233506453 0233506454 0233506455 0233506456 BOX07405V1 UDI-DI 00763000960186 Lot 0233617676 BOX01056V2 UDI-DI 00763000593711 Lot 0233484641 BOX01482V2 UDI-DI 00763000457990 Lot 0233607201 BOX09222V1 UDI-DI 00199150066636 Lot 0233577301 BOX08767V1 UDI-DI 00199150034338 Lot 0233598575 JAWBYPASS2 UDI-DI 00763000931988 Lots 0233608008 0233608009 BOX02191V11 UDI-DI 00199150038022 Lots 0233514888 0233586164 0233586169 0233587200 0234047180 BOX06863V4 UDI-DI 00763000991654 Lots 0233560359 0234087501 PST04884V3 UDI-DI 00763000523954 Lots 0233514943 0234035336 PST04884V6 UDI-DI 00763000646820 Lots 0233476937 0233550564 0233609032 BOX08506V2 UDI-DI 00199150028627 Lots 0234121845 0234122488 0234122495 0234122500 0234122505 0234122509 KIT00625V1 UDI-DI 00199150033874 Lot 0233646102 KIT01026V1 UDI-DI 00199150033867 Lot 0233646101 BOX00051V4 UDI-DI 00763000967765 Lots 0233560350 0233570153 0233584284 0233606897 PST03130V2 UDI-DI 00763000911096 Lot 0233628870 UCKGB5 UDI-DI 00763000910549 Lot 0233600730 WEJRYGB3 UDI-DI 00763000975326 Lot 0233547345 VLOCL0013 UDI-DI 20884521130361 Lot A5M1176VFY VLOCL0014 UDI-DI 20884521130378 Lot A6A0972VFY VLOCL0023 UDI-DI 20884521130408 Lot A5M1175VFY VLOCL0024 UDI-DI 20884521130415 Lot A5M1224VFY VLOCL0306 UDI-DI 10884521130944 Lot A6A0996VY UDI-DI 20884521130941 Lot A6A0996VY VLOCL0316 UDI-DI 10884521131316 Lot A5M1060VY UDI-DI 20884521131313 Lots A5M1060VY A6A0994VY VLOCL0345 UDI-DI 20884521131047 Lot A5M1165VY VLOCL0436 UDI-DI 20884521131085 Lot A5M1036VY VLOCL0604 UDI-DI 20884521131139 Lot A5M0869VY UDI-DI 10884521131132 Lots A5M0869VY A5M1179VY A5M1181VY A5M1182VY UDI-DI 20884521131139 Lots A5M0869VY A5M1179VY A5M1180VY A5M1181VY A5M1182VY VLOCL0615 UDI-DI 20884521131160 Lot A5M1245VY VLOCL0625 UDI-DI 20884521131238 Lot A6A1000VY VLOCL0644 UDI-DI 20884521131269 Lot A5M1163VY VLOCL0804 UDI-DI 10884521131286 Lots A5M1064VY A5M1205VY UDI-DI 20884521131283 Lots A5M1064VY A5M1205VY A6A1004VY VLOCL2105 UDI-DI 10884521131538 Lot A6A1003VY UDI-DI 20884521131535 Lots A5M1183VY A6A1003VY VLOCL2145 UDI-DI 10884521131545 Lot A6A1001VY UDI-DI 20884521131542 Lots A5M1164VY A6A1001VY VLOCL2246 UDI-DI 20884521762494 Lot A6A0998VY", "more_code_info": "" } ] }