{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "219499", "product_res_number": "Z-2007-2026", "event_date_initiated": "2026-03-17", "event_date_posted": "2026-05-06", "recall_status": "Open, Classified", "res_event_number": "98698", "product_code": "LRO", "product_description": "Medical Action Industries Inc. \nPack Cath BHH, \nREF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case", "code_info": "UDI:20809160490294/ Lot numbers: 342509, 346066, 338434, 339423, 337365, 335489, 336189, 336789", "firm_fei_number": "1030451", "recalling_firm": "Medical Action Industries, Inc. 306", "address_1": "25 Heywood Rd", "city": "Arden", "state": "NC", "postal_code": "28704-9302", "additional_info_contact": "Marlene Jones\n470-280-4277", "reason_for_recall": "Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold\"", "root_cause_description": "Unknown/Undetermined by firm", "action": "On April 22, 2026, Medial Action Industries, Inc. (subsidiary of Owens & Minor) issued a \"Urgent: Medical Device Recall Notification Update\" via E-Mail to affected consignees. The updated notification provided clarity and and additional information for the recall strategy. Initial notification was issued on March 17, 2026. Medical Action Industries asked consignees to take the following actions: \n\n1. Identify, segregate, and quarantine all impacted product. Convenience kits can still be used once properly labeled.\n\n2. Add warning labels to affected Medical Action kits to ensure all users are aware of the actions below and identified in the Medline recall notice. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. Please contact your Sales Representative if pre-printed labels are needed. \n\n3. If your firm used the labeling template provided with the initial letter, please adhere the revised label over the existing template label. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling.\n\n3. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have.\n\n4. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness.\n\n5. Complete the attached Recall Response Form and return by April 30, 2026.\n\nIf you have any questions, contact Reg. Affairs Manager, Kitting, Global Products, by email: GM-OMRA_RECALLS@owens-minor.com or 470-280-4277.", "product_quantity": "2030 kits", "distribution_pattern": "US distribution to state of: AZ\nOUS: None", "openfda": { "k_number": [ "K970187", "K871434", "K890570", "K902887", "K935741", "K935740", "K023276", "K931758", "K980137", "K950574", "K945831", "K872448", "K890726", "K872011", "K914037", "K914036", "K920267", "K932221", "K924468", "K895202", "K931760", "K951149", "K961863", "K920292", "K854292", "K934428", "K874439", "K910365", "K963443", "K913136", "K890729", "K934028", "K854095", "K881083", "K871459", "K871322", "K905004", "K894685", "K935483", "K971061", "K935686", "K041080", "K964921", "K885090", "K213481", "K892389", "K925467", "K944044", "K970286", "K212258", "K963715", "K905459", "K951478", "K931824", "K902293", "K925016", "K922648", "K903336", "K934029", "K961683", "K931844", "K930700", "K871873", "K932652", "K030721", "K925214", "K932217", "K880942", "K971062", "K930270", "K874760", "K890658", "K962826", "K893814", "K931673", "K922133", "K914174", "K941846", "K935743", "K926269", "K882684", "K936117", "K883250", "K931820", "K842648", "K935858", "K923600", "K871437", "K933137", "K945160", "K880961", "K953083", "K932220", "K965201", "K964011", "K934030", "K931759", "K910368", "K945481", "K873973", "K934688", "K901856", "K963721", "K950295", "K914935", "K884093", "K902888", "K925216", "K890098", "K952539" ], "registration_number": [ "3009203853", "3013735189", "9611024", "1061124", "1066741", "3006191977", "1060680", "3009888344", "3014325891", "3013421458", "3009637528", "1063382", "3004122598", "3014704068", "3005012805", "2936485", "3008496560", "3006450239", "1527607", "3012811961", "3007829657", "1065597", "3014718111", "9681709", "3003924117", "3017430544", "8022210", "3010878085", "3004519921", "3027977504", "3011494917", "9616088", "1721686", "3003495693", "3043620414", "3010305275", "3010452421", "1610287", "3014421917", "3004362278", "1123010", "2024311", "3016761372", "1423395", "1420054", "3007329020", "3007082897", "3030078769", "2433012", "3013298431", "1043214", "3014680744", "1423537", "9614277", "3004361903", "3004713352", "3006400329", "3009773841", "3007289408", "3026197444", "1650907", "9611594", "2431166", "3006673317", "9680143", "3018071447", "3012595397", "3006846316", "1055236", "3002807314", "2000028362", "1018470", "9680425", "3002669946", "3006271008", "3013502418", "1823410", "3044906632", "3007139365", "3013960812", "3004513970", "3045816902", "3015058854", "3016096096", "1030451", "2024980", "8030678", "3006540014", "1424263", "2648727", "3014925393", "3011500469", "1054241", "3006891803", "1047843", "1643817", "3015960676", "1000124971", "1644019", "3004605321", "3013466775", "1923569", "1121203", "3018077422", "1526711", "3005400762", "9680357", "3031841433", "9616096", "3011707784", "2029015", "3006973666", "3004911384", "3015895045", "3006542380", "3005391805", "3017636737", "3020983482", "1928237", "8022032", "1921846", "3002806603", "3041276890", "3017467279", "3011270181", "3013600605", "3045816907", "3042158935", "3005669815", "3023140882", "3011532690", "3010166880", "3011545608", "3011144486", "8030672", "1417592", "3005246893", "3045857302", "3042480961", "1824619", "2320762", "3004111573", "3011554160", "1055892", "3007344957", "3008824097", "3035642068", "2029275", "3005997949", "1422634", "3015173212", "3007007790", "3036002406", "1055954", "3008403546", "3005595283", "3018116884", "3009750712", "1047429", "3010376936", "3019798849", "2011171" ], "fei_number": [ "3009203853", "3013735189", "3006191977", "1000208624", "3009888344", "3014325891", "3013421458", "3009637528", "3004122598", "3005012805", "3014704068", "1000112877", "3000718854", "2936485", "3008496560", "3006450239", "1527607", "1000111202", "3012811961", "3007829657", "3003924117", "3017430544", "3003803331", "3010878085", "3027977504", "3011494917", "1721686", "3003495693", "3043620414", "3010305275", "3010452421", "1610287", "3014421917", "3001236905", "3004362278", "2024311", "3016761372", "1000512168", "1420054", "1000306431", "3007329020", "3007082897", "3003040625", "3030078769", "2433012", "3013298431", "1043214", "3014680744", "3008373372", "3004713352", "3006400329", "3004361903", "3009773841", "3007289408", "3026197444", "3003015552", "3018071447", "3012595397", "3006846316", "3003005156", "3001717360", "3002805559", "3002807314", "2000028362", "1018470", "3932", "3002669946", "3006271008", "3013502418", "1823410", "3044906632", "3007139365", "3013960812", "3004513970", "3045816902", "3015058854", "3016096096", "1030451", "2523865", "3006540014", "1000117501", "2648727", "3000215259", "3014925393", "3011500469", "3006891803", "1047843", "1000121355", "1643817", "3015960676", "1000124971", "3004605321", "3013466775", "3002806436", "1923569", "3000717925", "3018077422", "3004829691", "1526711", "3002681132", "3005596530", "3005400762", "3031841433", "3005846326", "1000160458", "3011707784", "3006973666", "3004911384", "3015895045", "3006542380", "3005391805", "1000113384", "3017636737", "3020983482", "1928237", "3002807308", "1000123297", "3002806603", "1921846", "3041276890", "3017467279", "3011270181", "3013600605", "3045816907", "1000112968", "3042158935", "3005669815", "3023140882", "3011532690", "3010166880", "3011545608", "3011144486", "1417592", "3005246893", "3008875470", "3045857302", "3042480961", "1824619", "1000514656", "3004111573", "3011554160", "3007344957", "3008824097", "3035642068", "3005997949", "3015173212", "3007007790", "3002807170", "3036002406", "3194", "3007596547", "3008403546", "3002692512", "3005595283", "3018116884", "3009750712", "1047429", "3010376936", "3003807323", "3019798849", "2011171", "3002902735" ], "device_name": "General Surgery Tray", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4370", "device_class": "2" } } ] }