{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217666", "product_res_number": "Z-1035-2026", "event_date_initiated": "2025-11-21", "event_date_posted": "2026-01-08", "recall_status": "Open, Classified", "res_event_number": "98125", "product_code": "BYG", "product_description": "Medline Hudson RCI Medium Concentration Oxygen Masks:\n\n1041CE\nMASK,OXYGEN,UND CHIN,MED CO OUS ONLY;\nHUD1035\nO2 MASK,MED CONC,SHORT,PEDI,7' TUB SC;\nHUD1042\nO2 MASK,MED CONC,PEDI,7' TUB SC;\nHUD1930\nO2 MASK,MED CONC,ADULT,7' TUB UC;\nHUDRHO41U\nMASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC", "code_info": "UDI:\n1041CE \n00888277446727 (ea) \n40888277446725 (case);\n\nHUD1035\n10197344011575 (ea)\n20197344011572 (case);\n\nHUD1042\n10197344011544 (ea)\n20197344011541 (case);\n\nHUD1930\n10197344009626 (ea)\n20197344009623 (case);\n\nHUDRHO41U\n10197344010646 (ea)\n20197344010643 (case)\n\nLots:\n\n24DOA701\n25EOA321\n25EOA589\n25EOA724\n25EOA730\n25EOA781\n25EOA857\n25FOA151\n25FOA152\n25FOA153\n25FOA206\n25FOA218\n25FOA219\n25FOA220\n25FOA221\n25FOA275\n25FOA287\n25FOA288\n25FOA418\n25FOA419\n25FOA420\n25FOA421\n25FOA422\n25FOA514\n25FOA515\n25FOA524\n25FOA525\n25FOA551\n25FOA552\n25FOA553\n25FOA556\n25FOA557\n25FOA642\n25FOA643\n25FOA647\n25FOA648\n25FOA649\n25FOA650\n25FOA722\n25FOA740\n25FOA864\n25FOA865\n25FOA866\n25GOA055\n25GOA065\n25GOA066\n25GOA077\n25GOA078\n25GOA096\n25GOA098\n25GOA190\n25GOA210\n25GOA211\n25GOA328\n25GOA363\n25GOA364\n25GOA365\n25GOA366\n25GOA367\n25GOA437\n25GOA445\n25GOA446\n25GOA561\n25GOA562\n25GOA563\n25GOA564\n25GOA565\n25GOA640\n25GOA641\n25GOA648\n25GOA655\n25GOA735\n25GOA736\n25GOA756\n25GOA757\n25GOA758\n25GOA759\n25GOA760\n25GOA761\n25GOA766\n25GOA830\n25GOA994\n25GOA998\n25HOA009\n25HOA011\n25HOA017\n25HOA018\n25HOA019\n25HOA020\n25HOA021\n25HOA022\n25HOA060\n25HOA061\n25HOA071\n25HOA247\n25HOA249\n25HOA252\n25HOA253\n25HOA254\n25HOA255\n25HOA256\n25HOA316\n25HOA335\n25HOA372\n25HOA373\n25HOA452\n25HOA455\n25HOA456\n25HOA457\n25HOA458\n25HOA459\n25HOA460\n25HOA462\n25HOA469\n25HOA474\n25HOA478\n25HOA532\n25HOA533\n25HOA538\n25HOA629\n25HOA630\n25HOA631\n25HOA632\n25HOA633\n25HOA639\n25HOA644\n25HOA723\n25HOA724\n25HOA734\n25HOA829\n25HOA830\n25HOA831\n25HOA832\n25HOA833\n25HOA853\n25IOA020\n25IOA021\n25IOA090\n25IOA097\n25IOA163\n25IOA164\n25IOA165\n25IOA166\n25IOA244\n25IOA246\n25IOA247\n25IOA253\n25IOA363\n25IOA364\n25IOA365\n25IOA366\n25IOA367\n25IOA368\n25IOA369\n25IOA410\n25IOA438\n25IOA439\n25IOA520\n25IOA521\n25IOA522\n25IOA523\n25IOA524\n25IOA525\n25IOA526\n25IOA527\n25IOA637\n25IOA638\n25IOA668\n25IOA682\n25IOA683\n25IOA684\n25IOA685\n25IOA686\n25IOA687\n25IOA688\n25IOA743\n25IOA787\n25JOA027\n25JOA032\n25JOA047\n25JOA048\n25JOA049\n25JOA050\n25JOA051\n25JOA052\n25JOA053\n25JOA179\n25JOA213\n25JOA215\n25JOA243\n25JOA246\n25JOA247\n25JOA248\n25JOA249\n25JOA250\n25JOA251\n25JOA252\n25JOA253\n25JOA386\n25JOA430\n25JOA467\n25JOA561\n25JOA562\n25JOA563\n25JOA564\n25JOA579\n25JOA670\n25JOA675\n25JOA757\n25JOA758\n25JOA760\n25JOA762\n25JOA763\n25JOA778\n25JOA779\n25JOA780\n25JOA832\n25JOA835\n25JOA856\n25JOA940\n25JOA941\n25JOA942\n25KOA050\n25KOA051", "firm_fei_number": "1417592", "recalling_firm": "Medline Industries, LP", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "reason_for_recall": "Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.", "root_cause_description": "Under Investigation by firm", "action": "On November 21, 2025, the firm notified customers via Urgent Medical Device Recall letter.\n\nCustomers were instructed to destroy affected product on hand. No product is being returned to Medline. For kits, Medline instructed customers to request stickers to over-label the affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply.", "product_quantity": "1,611,081 eaches", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Bahamas, Canada, China, Dominican Republic, Guam, South Korea, Mexico, Panama, and Singapore.", "openfda": { "k_number": [ "K852624", "K892434", "K904719", "K760941", "K850626", "K953464", "K874092", "K810340", "K801883", "K913455", "K865047", "K913501", "K760329", "K962848", "K772141", "K852626", "K905288", "K894642", "K802323", "K890193", "K852629", "K942907", "K912633", "K790165", "K781055", "K760219", "K823141", "K823532", "K860870", "K790934", "K870206", "K945472", "K790164", "K790163", "K924069", "K811711", "K913383", "K790166", "K770995", "K963298", "K860871", "K953039", "K781741", "K852623", "K940887", "K945482", "K940888", "K904195", 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"3010149039", "3017385563", "3010880718", "3006210673", "3015168843", "3016758972", "3045742729", "3008048818", "3006363476", "3017684630", "3018762668", "3020614", "3038236812", "3009747810", "3042896810", "3010402691", "3006446479", "3012309743", "3010374920", "3004604967", "3012494290", "3016458361", "3044994756", "3011987967", "3013187142", "3004488394", "3006157842", "3010957755", "3015422337", "3030017177", "3008806809", "3013557562", "3005160810", "3004993040", "3002806988", "3005669815" ], "device_name": "Mask, Oxygen", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5580", "device_class": "1" } } ] }