{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "205403", "product_res_number": "Z-0845-2024", "event_date_initiated": "2023-12-21", "event_date_posted": "2024-01-29", "recall_status": "Open, Classified", "res_event_number": "93768", "product_code": "GAP", "k_numbers": [ "K981128" ], "product_description": "Sofsilk Braided Silk sutures:\n\nCS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36\nGS-831 SOFSILK* 4-0 BLK 75CM V20 X36\nS-176 SOFSILK* 0 BLK 12X45CM PCT X24\nS-182 SOFSILK* 5-0 BLK 12X45CM PCT X36\nS-184 SOFSILK* 3-0 BLK 12X45CM PCT X36\nS-185 SOFSILK* 2-0 BLK 12X45CM PCT X36\nS-245 SOFSILK* 2-0 BLK 12X60CM PCT X36\nS-246 SOFSILK* 0 BLK 6X60CM PCT X36\nS-2782K SOFSILK* 4-0 WHI 45CM SS24 DA\nS-303 SOFSILK* 4-0 BLK 12X75CM PCT X36\nS-304 SOFSILK* 3-0 BLK 12X75CM PCT X36\nS-305 SOFSILK* 2-0 BLK 12X75CM PCT X36\nS-316 SOFSILK* 0 BLK 12X75CM PCT X24\nS-317 SOFSILK* 1 BLK 12X75CM PCT X24\nS-605 SOFSILK* 2-0 BLK 2X150CM PCT X36\nS-606 SOFSILK* 0 BLK 2X150CM PCT X36\nS606-12 SOFSILK* 0 BLK 2X150CM PCT X12\nS-610 SOFSILK* 5 BLK 2X150CM PCT X12\nSOFSILK 2-0 30 BK CV-24 GS453-2\nSOFSLK 4-0 24 BK CV-15 DA VS581-2\n\n***Added 4/1/24***\nCS-792 SOFSILK* 0 BLK 100CM GCC90 X36\nS-1172 SOFSILK* 6-0 BLK 45CM C1 X36\nS-1735 SOFSILK* 4-0 BLK 30CM C1 DA X12\nS-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12\nS-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12\nS-1789K SOFSILK* 4-0 BLK 45CM HE3 X12\nS-187 SOFSILK* 1 BLK 6X45CM PCT X36\nS-243 SOFSILK* 4-0 BLK 12X60CM PCT X36\nS-2780K SOFSILK* 6-0 BLK 45CM SS-24DA\nS-282 SOFSILK* 5 BLK 3X60CM PCT X36\nS-318 SOFSILK* 2 BLK 12X75CM PCT X24\nS-608 SOFSILK* 2 BLK 2X150CM PCT X36\nVS-872 SOFSILK* 3-0 BLK 75CM CV23 X36\nVS872-2 SOFSILK 3-0 30 BK CV-23 VS872-2\nSS-1694G SOFSILK 4/0 BLK 45CM P24 X12\nSS-5641 SOFSILK* 4-0 BLK 45CM P13 X36\nSS-5649G SOFSILK* 6-0 BLK 45CM P13 X12\nSS-645 SOFSILK* 4-0 BLK 75CM C12 X36\nSS-675 SOFSILK* 3-0 BLK 75CM C16 X36\nSS-681 SOFSILK* 6-0 BLK 45CM C12 X36\nVS-872 SOFSILK* 3-0 BLK 75CM CV23 X36\nXX-5280 SOFSILK* 0 BLK 150CM PCT X36\n--\n\nTi-Cron Coated Braided Polyester Sutures:\n\n3087-31 TICRON* 4-0 BLU 75CM CV-331DA\n3226-31 TICRON* 4-0 BLU 60CM CV330 DA\n88863026-71 TICRON* 1 BLU 75CM HOS12X36\n88863070-51 TICRON* 2-0 BLU 75CM C15X36\n88863087-31 TICRON* 4-0 BLU 75CM CV33DA\n88863092-71 TICRON* 1 BLU 75CM KV37X36\n88863147-83 TICRON 2 BLU 5X75CM KV37X12\n88863185-41 TICRON* 3-0 BLU 75CM CV305\n88863186-31 TICRON* 4-0 BLU 75CM CV331\n88863226-31 TICRON* 4-0 BLU 60CM CV330DA\n88863226-41 TICRON* 3-0 BLU 60CM CV330DA\n88863229-31 TICRON* 4-0 BLU 75CM CV307DA\n88863271-31 TICRON* 4-0 BLU 90CM CV331DA\n88863309-71 TICRON* 1 BLU 75CM GS11X36\n--\nMonosof Monofilament Nylon Sutures:\n\nN-63 MONOSOF* 3-0 BLK 12X45CM PCT X36\nSN-3695 MONOSOF* 5-0 BLK 45CM P10 X12\n\n--\nSteel Monofilament Stainless Steel Sutures\n\n88862224-49 STEEL 7 4X45CM SCC X12", "code_info": "Model CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36\nUDI-DI 20884521083629\nLot\nD1L1576RY\n\nModel GS-831 SOFSILK* 4-0 BLK 75CM V20 X36\nUDI-DI 20884521085203\nLot D2B1216RY\n\nModel S-176 SOFSILK* 0 BLK 12X45CM PCT X24\nUDI-DI 20884521085746\nLot D2D0612RY\n\nModel S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36\nUDI-DI 20884521085944\nLot D2B0728RY\n\nModel S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36\nUDI-DI 20884521085968\nLots \nD2D0972RY\nD2E2396RY\n\nModel S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36\nUDI-DI 20884521085975\nLots\nD2D0957RY\nD2D0968RY\nD2D0971RY\nD2D0984RY\nD2D0985RY\nD2E0900RY\nD2E0902RY\n\n\nModel S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36\nUDI-DI 10884521086197\nLot D2E0674RY\nUDI-DI 20884521086194\nLots\nD2D1871RY\nD2E0674RY\nD2E0901RY\n\nModel S-246 SOFSILK* 0 BLK 6X60CM PCT X36\nUDI-DI 20884521086200\nLot D2D0980RY\n\nModel S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA\nUDI-DI 20884521086422\nLot D2F2101RY\n\nModel S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36\nUDI-DI 20884521086460\nLots\nD2D1872RY\nD2D2120RY\n\nModel S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36\nUDI-DI 20884521086477\nLot D2D1991RY\n\nModel S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36\nUDI-DI 20884521086484\nLots\nD2E0907RY\nD2E2685RY\n\nModel S-316 SOFSILK* 0 BLK 12X75CM PCT X24\nUDI-DI 20884521086491\nLot D2D2436RY\n\nModel S-317 SOFSILK* 1 BLK 12X75CM PCT X24\nUDI-DI 20884521086514\nLot D2E0587RY\n\nModel S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36\nUDI-DI 20884521086620\nLot D2E0676RY\n\nModel S-606 SOFSILK* 0 BLK 2X150CM PCT X36\nUDI-DI 10884521086630\nLot D2B2638RY\nUDI-DI 20884521086637\nLots\nD2B2638RY\nD2D0961RY\n\nModel S606-12 SOFSILK* 0 BLK 2X150CM PCT X12\nUDI-DI 10884521637887\nLot D2D0961RY\n\nModel S-610 SOFSILK* 5 BLK 2X150CM PCT X12\nUDI-DI 20884521086675\nLot D2B1535RY\n\nModel SOFSILK 2-0 30 BK CV-24 GS453-2\nUDI-DI 20884521758121\nLots\nD2D0254RY\nD2D1576RY\n\nModel SOFSLK 4-0 24 BK CV-15 DA VS581-2\nUDI-DI 20884521757971\nLot D2E1431RY\n\n***Added 4/1/24***\n\nModel CS-792 SOFSILK* 0 BLK 100CM GCC90 X36\nUDI-DI 20884521084756\nLot D2C0576RY\n\nModel S-1172 SOFSILK* 6-0 BLK 45CM C1 X36\nUDI-DI 20884521085470\nLot D2J0691RY\n\nModel S-1735 SOFSILK* 4-0 BLK 30CM C1 DA X12\nUDI-DI 20884521085630\nLot D1L3318FRY\n\nModel S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12\nUDI-DI 20884521085739\nLot D2E2348RY\n\nModel S-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12\nUDI-DI 20884521085784\nLot D2B2217RY\n\nModel S-1789K SOFSILK* 4-0 BLK 45CM HE3 X12\nUDI-DI 20884521085876\nLot D2D0262RY\n\nModel S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36\nUDI-DI 20884521085975\nLots \nD2B2878RY\nD2E2680RY\nD2E2769RY\n\nModel S-187 SOFSILK* 1 BLK 6X45CM PCT X36\nUDI-DI 20884521085982\nLot D2A1585RY\n\nModel S-243 SOFSILK* 4-0 BLK 12X60CM PCT X36\nUDI-DI 20884521086170\nLots \nD1M1020RY\nD2D2348RY\nD2E1492RY\n\nModel S-246 SOFSILK* 0 BLK 6X60CM PCT X36\nUDI-DI 10884521086203\nLot D2E1375RY\nUDI-DI 20884521086200\nLots D2E1375RY\nD2E1488RY\n\nModel S-2780K SOFSILK* 6-0 BLK 45CM SS-24DA\nUDI-DI 20884521086408\nLot D2C1916RY\n\nModel S-282 SOFSILK* 5 BLK 3X60CM PCT X36\nUDI-DI 20884521086453\nLot D2E1470RY\n\nModel S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36\nUDI-DI 20884521086460\nLots D2E1495RY\nD2E1496RY\n\nModel S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36\nUDI-DI 20884521086477\nLot D2E1472RY\n\nModel S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36\nUDI-DI 20884521086484\nLots D2C1479RY\nD2E2772RY\n\nModel S-318 SOFSILK* 2 BLK 12X75CM PCT X24\nUDI-DI 20884521086538\nLots D1M0153RY\nD2A1677RY\n\nModel SS-1694G SOFSILK 4/0 BLK 45CM P24 X12\nUDI-DI 20884521176406\nLot D1M0141FRY\n\n\nModel S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36\nUDI-DI 20884521086620\nLot D2E1491RY\n\nModel S-608 SOFSILK* 2 BLK 2X150CM PCT X36\nUDI-DI 20884521086668\nLots D1M0173RY\nD1M0635RY\nD2E1210RY\n\nModel VS872 SOFSILK* 3-0 BLK 75CM CV23 X36\nUDI-DI 20884521090184\nLot D1M1837RY\n\nModel VS872-2 SOFSILK 3-0 30 BK CV-23 VS872-2\nUDI-DI 20884521758060\nLot D2B1783RY\n\nModel SS-5641 SOFSILK* 4-0 BLK 45CM P13 X36\nUDI-DI 20884521086774\nLot D2B2181FRY\n\nModel SS-5649G SOFSILK* 6-0 BLK 45CM P13 X12\nUDI-DI 20884521086804\nLot D2C1987FRY\n\nModel SS-645 SOFSILK* 4-0 BLK 75CM C12 X36\nUDI-DI 20884521087580\nLot D1M2531FRY\n\nModel SS-675 SOFSILK* 3-0 BLK 75CM C16 X36\nUDI-DI 20884521087726\nLot D1K1916FRY\n\nModel SS-681 SOFSILK* 6-0 BLK 45CM C12 X36\nUDI-DI 20884521087924\nLot D2G0795FRY\n\nModel VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36\nUDI-DI 20884521090184\nLot D1M1837RY\n\nModel XX-5280 SOFSILK* 0 BLK 150CM PCT X36\nUDI-DI 20884521106045\nLot D2E1482RY\n\n--\nTi-Cron Coated Braided Polyester Sutures:\n\n3087-31 TICRON* 4-0 BLU 75CM CV-331DA\nUDI-DI 10884521632271\nLot D1M2840RY\n\n3226-31 TICRON* 4-0 BLU 60CM CV330 DA\nUDI-DI 10884521632547\nLot D2G1007RY\n\n88863026-71 TICRON* 1 BLU 75CM HOS12X36\nUDI-DI 20884521059129\nLot D2C1802RY\n\n88863070-51 TICRON* 2-0 BLU 75CM C15X36\nUDI-DI 20884521059570\nLot D2C3250FRY\n\n88863087-31 TICRON* 4-0 BLU 75CM CV33DA\nUDI-DI 10884521059832\nLot D1M2840RY\n\n88863092-71 TICRON* 1 BLU 75CM KV37X36\nUDI-DI 20884521059990\nLot D2C2450RY\n\n88863147-83 TICRON 2 BLU 5X75CM KV37X12\nUDI-DI 10884521060340\nLot D1K0110RY\n\n88863185-41 TICRON* 3-0 BLU 75CM CV305\nUDI-DI 20884521061191\nLot D2C0774RY\n\n88863186-31 TICRON* 4-0 BLU 75CM CV331\nUDI-DI 10884521061279\nLot D2G1004RY\nUDI-DI 20884521061276\nLot D2G1004RY\n\n88863226-31 TICRON* 4-0 BLU 60CM CV330DA\nUDI-DI 20884521061634\nLot D2G1007RY\n\n88863226-41 TICRON* 3-0 BLU 60CM CV330DA\nUDI-DI 20884521061641\nLot D2A0451RY\n\n88863229-31 TICRON* 4-0 BLU 75CM CV307DA\nUDI-DI 20884521061689\nLot D2G1307RY\n\n88863271-31 TICRON* 4-0 BLU 90CM CV331DA\nUDI-DI 10884521062177\nLot D2F2152RY\nUDI-DI 20884521062174\nLot D2F2152RY\n\n88863309-71 TICRON* 1 BLU 75CM GS11X36\nUDI-DI 20884521062488\nLot D2D2188RY\n\n--\nMonosof Monofilament Nylon Sutures:\n\nN-63 MONOSOF* 3-0 BLK 12X45CM PCT X36\nUDI-DI 20884521076607\nLot D2A0862RY\n\nSN-3695 MONOSOF* 5-0 BLK 45CM P10 X12\nUDI-DI 20884521077994\nLot D2C1333FRY\nD2H1541FRY\n\n--\nSteel Monofilament Stainless Steel Sutures\n\n88862224-49 STEEL 7 4X45CM SCC X12\nUDI-DI 20884521102351\nLot D3B1366RY", "firm_fei_number": "1282497", "recalling_firm": "Covidien LP", "address_1": "15 Hampshire St", "city": "Mansfield", "state": "MA", "postal_code": "02048-1113", "additional_info_contact": "Technical Service\n800-962-9888 Ext. 2", "reason_for_recall": "Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.", "root_cause_description": "Process control", "action": "On December 21, the firm notified affected consignees via URGENT MEDICAL DEVICE RECALL letters. \n\nCustomers were instructed to identify, quarantine, and return all unused, non-expired affected sutures to Medtronic. Please contact rs.covidienfeedbackcustomerservice@medtronic.com for the Return Good Authorization (RGA). Customers will receive credit for returned affected product. If purchased from a distributor, please contact your distributor directly to arrange for the return of product back to your distributor.\n\nPass on the recall notice to all those who need to be aware within your organization, or to any organization where the affected sutures have been transferred or distributed.\n\nIf you have questions regarding this recall, please call Medtronic Quality Assurance at 800-255-6774 option 1, then option 1\n\n***Updated 4/1/2024***\nFirm identified additional models and lots affected by the gamma radiation issue and sent additional notification to customers on January 25, 2024.", "product_quantity": "46,812 US; 68,976 OUS", "distribution_pattern": "Worldwide US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, HI, IA, IL, IN, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, PR, TN, TX, VA, WA, WV and the countries of Australia, Bahrain, Belgium, Bulgaria, Canary Islands, China, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic Of Kosovo, Mongolia, Netherlands, New Zealand, Panama, Poland, Portugal, Puerto Rico, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom.", "openfda": { "k_number": [ "K020901", "K053638", "K761199", "K964581", "K024091", "K071111", "K980124", "K003001", "K931913", "K000541", "K981128", "K993999", "K943627", "K162396", "K982853", "K232355", "K760650", "K942234", "K180701", "K172149", "K960328", "K080684", "K905287", "K930826", "K012124", "K222944", "K001184", "K930739", "K905454", "K904478", "K041514", "K023029", "K760158", "K160623", "K241486", "K904891", "K221767", "K042282", "K930825", "K990089", "K994177" ], "pma_number": [ "N85143", "N84348", "N84047", "N80989", "N11397" ], "registration_number": [ "3002579136", "3016851379", "3014461810", "3015806723", "3019269298", "3015974593", "3013403214", "3013700547", "2648623", "3006981798", "3007205024", "3004215117", "3012421607", "3006498370", "2032098", "2530154", "1037089", "1018470", "3014262693", "3043226252", "3010162973", "3016727307", "1000274611", "3027242374", "1048735", "3011276344", "3009968482", "3003418325", "3021226419", "3010452421", "1064514", "3044819802", "1064584", "3010692967", "3014615644", "3005953126", "3020983460", "3012502601", "3016426842", "3045855232", "3003267729", "9710098", "9680794", "2210968", "3032543753", "3007791599", "9611459", "3008483449", "1054811", "1450662", "1221051", "3015183635", "3030733800", "1061124", "2523835", "3015231789", "3027339877", "3045857302", "3017102971", "3012329552", "3013298431", "3014004349", "3013187142", "1017294", "3006638824", "3004111573", "3002692886", "3012494290", "3018052045", "3018094310", "1062741", "3014276972", "3010041511", "3016904853", "1219930", "3004845555", "3011137372", "1064017", "3006562124", "3029754081", "1043214", "3011230048", "3020704423", "3004192065", "3015859709", "3010400367", "1061927", "1066741", "3011689956", "2648650", "3010864832", "3038718579", "3007109793", "3004944585", "1221601", "1055236", "9612501", "9616088", "3009423112", "2183301", "3010131137", "1423537", "3009513193", "3029901632", "3014592276", "3017196117", "3006425876", "2030624", "2521877", "1721676", "3014273254", "3004117249", "3010331645", "3007791573", "1058584", "1054241", "2320762", "3012101664", "3014579161", "3015330532", "3004365956", "3008912461", "3003639970", "1220246" ], "fei_number": [ "3002579136", "3016851379", "3014461810", "3015806723", "3019269298", "3015974593", "3003063934", "3013403214", "3013700547", "2648623", "3006981798", "3007205024", "3004215117", "3012421607", "3006498370", "1037089", "1018470", "3014262693", "3043226252", "3016727307", "1000274611", "3027242374", "1048735", "3011276344", "3002807041", "3009968482", "3003418325", "3021226419", "3010452421", "3044819802", "3005953126", "3010692967", "3014615644", "3020983460", "3012502601", "3016426842", "3045855232", "3003267729", "2210968", "3032543753", "3004161528", "3007791599", "3002957101", "3008483449", "1450662", "1221051", "3015183635", "3030733800", "2523835", "3015231789", "3027339877", "3045857302", "3017102971", "3012329552", "3013298431", "3014004349", "3013187142", "1000112877", "1000114185", "1017294", "3006638824", "3004111573", "1000219637", "3002692886", "3012494290", "3018052045", "3003737899", "3018094310", "3014276972", "3010041511", "3016904853", "1219930", "3004845555", "1000112968", "3029754081", "3006562124", "1043214", "3011230048", "3010862763", "3020704423", "3004192065", "3000190635", "3015859709", "3000302153", "1000307073", "3003005156", "3000203000", "3001236905", "3010400367", "3011689956", "2648650", "3038718579", "3007109793", "3004944585", "1221601", "1000512168", "3009423112", "2183301", "3010131137", "3003058448", "3009513193", "3029901632", "3014592276", "3017196117", "3006425876", "3000206435", "1721676", "2521877", "3014273254", "3004117249", "3002807993", "3010331645", "3007791573", "3012101664", "3002902735", "3005747797", "3014579161", "3003495548", "3015330532", "3004365956", "3008912461", "3003639970", "1220246", "3003040625" ], "device_name": "Suture, Nonabsorbable, Silk", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.5030", "device_class": "2" } } ] }