{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "195686", "product_res_number": "Z-1773-2022", "event_date_initiated": "2022-08-08", "event_date_created": "2022-09-20", "recall_status": "Open, Classified", "res_event_number": "90764", "product_code": "NEW", "product_description": "PDS II (polydioxanone) Suture, Product Code Z771D\n\n4-0 PDS Suture, Violet, 8x18\" (45cm), SH-1 Control Release Needles", "code_info": "UDI-DI (GTIN): 10705031061705 (individual unit); 30705031061709 (sales unit box)\n\nProduct Number: Z771D; Lot No: SAMPAL", "firm_fei_number": "2210968", "recalling_firm": "Ethicon, Inc.", "address_1": "Us Highway 22 West", "city": "Somerville", "state": "NJ", "postal_code": "08876", "additional_info_contact": "908-218-0707", "reason_for_recall": "Product may contain the incorrect material which could impact treatment.", "root_cause_description": "Process control", "action": "Customer notification began August 8, 2022. The responsible Johnson & Johnson affiliates in Japan will be contacting all their impacted primary and secondary consignees and/or end customers. \nCustomers are asked to immediately check inventory for impacted product and to quarantine that product. In the event product has been forwarded to another facility, the customer shall contact that facility to arrange return. The customer shall complete the Business Reply Form (BRF) to confirm receipt of the recall notice within 3 business days. Customers are required to return unused impacted product per the recall letter instructions.", "product_quantity": "88 boxes (1056 ea)", "distribution_pattern": "Distribution in Japan only", "openfda": { "k_number": [ "K040004", "K113004", "K061037", "K120827", "K252171", "K141776", "K080918", "K261988", "K071989", "K150553", "K080985", "K250977", "K143413", "K190264", "K210871", "K073614", "K031216", "K123668", "K162366", "K160705", "K041048", "K120284", "K160761", "K232246", "K123877", "K022666", "K030212", "K242571", "K252644", "K250107", "K053380", "K031443", "K242835", "K252047", "K051609", "K042075", "K063680", "K201139", "K133420", "K172602", "K181582", "K130191", "K190245", "K182873", "K043298", "K100461", "K080680", "K113744", "K132268", "K192423", "K220549", "K251414", "K253879", "K240389", "K191361", "K082097", "K243897", "K100780", "K081001", "K161737", "K042285", "K030786", "K150670", "K192144", "K212380", "K013274" ], "pma_number": [ "N18331" ], "device_name": "Suture, Surgical, Absorbable, Polydioxanone", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4840", "device_class": "2", "registration_number": [ "3014527910", "3016010820", "3013187142", "3016904853", "3006981798", "3012494290", "2125050", "3013529787", "1721676", "3014615644", "2210968", "3016445763", "1614993", "3013298431", "3012421607", "3005953126", "3012502601", "9617547", "3004944585", "3008114965", "3003828812", "3014273254", "3030733800", "2648650", "3015289316", "3016244792", "2183744", "3011555199", "3014579161", "3010462274", "3015812758", "1054241", "3043226252", "3045855232", "3011689956", "3014272734", "2528981", "2650143", "3013403214", "3007791599", "3006680097", "1000274611", "1055236", "3010692967", "3023274465", "3020983460", "3005972890", "1043214", "3044819802", "3017936846", "3013376016", "3013354263", "3013557562", "3027329031", "1221934", "3010131137", "3008868758", "3038138322", "3029901632", "3006638824", "3004845555", "3004117249", "3030141376", "3004365956", "3002294946", "2246552", "3015138222", "3010041511", "3012438919", "3014461810", "3016560306", "3003267729", "1064584", "1221601", "3011137372", "3018052045", "3013589761", "3007895168", "3008912461", "3007205024", "1018470", "1320468", "3003639970", "2030624", "3017102971", "3010864832", "3006562124" ], "fei_number": [ "3014527910", "3016010820", "3013187142", "3016904853", "3006981798", "3012494290", "2125050", "3013529787", "1721676", "3003063934", "3014615644", "2210968", "3010862763", "3016445763", "1614993", "3013298431", "3012421607", "3005953126", "3012502601", "3004944585", "3008114965", "3003828812", "3014273254", "3030733800", "2648650", "3015289316", "3016244792", "2183744", "3011555199", "3005747797", "3014579161", "3010462274", "3015812758", "3043226252", "3045855232", "3011689956", "3014272734", "2528981", "1000112968", "3013403214", "3007791599", "3006680097", "1000274611", "3003272809", "3010692967", "3000206435", "3023274465", "3020983460", "3005972890", "1043214", "3044819802", "3017936846", "3013376016", "3013354263", "3013557562", "3000206455", "3027329031", "1221934", "3010131137", "3008868758", "3038138322", "3029901632", "2648209", "3006638824", "3004845555", "3004117249", "3030141376", "3004365956", "3002294946", "2246552", "3015138222", "3010041511", "3012438919", "3014461810", "3016560306", "3003267729", "1000112877", "1221601", "3018052045", "3013589761", "3007895168", "3008912461", "3007205024", "1018470", "3003639970", "3017102971", "3006562124" ] } } ] }