{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221198", "product_res_number": "Z-2760-2026", "event_date_initiated": "2026-06-19", "event_date_posted": "2026-07-17", "recall_status": "Open, Classified", "res_event_number": "99291", "product_code": "FPO", "product_description": "Power F2 Powered Fastening System, Product No. 0567091 \nPowered fastening system intended for professional use only. Designed to load, unload, and secure a compatible wheeled stretcher inside a ground-based ambulance.\n\nItem no. 0567091", "code_info": "UDI-DI 00190790006570\n\nSerial Numbers:\n25C227687\n25C228204\n26C232382\n26C233091\n25C227688\n25C228205\n26C232383\n26C233092\n25C227689\n26C231797\n26C232384\n26C233093\n25C227690\n26C231798\n26C232709\n26C233094\n25C227691\n26C231799\n26C232710\n26C233095\n25C227692\n26C231800\n26C232711\n26C233096\n25C227693\n26C231801\n26C232712\n26C233097\n25C227694\n26C232002\n26C232713\n26C233098\n25C227695\n26C232004\n26C232714\n26C233099\n25C227696\n26C232005\n26C232715\n26C233100\n25C227697\n26C232006\n26C232716\n26C233111\n25C227698\n26C232007\n26C232717\n26C233112\n25C227699\n26C232008\n26C232718\n26C233113\n25C227700\n26C232009\n26C233032\n26C233114\n25C227701\n26C232010\n26C233033\n26C233115\n25C227702\n26C232011\n26C233035\n26C233116\n25C227703\n26C232374\n26C233036\n26C233117\n25C227704\n26C232375\n26C233037\n26C233118\n25C227707\n26C232377\n26C233038\n26C233119\n25C227708\n26C232378\n26C233039\n26C233120\n25C227709\n26C232379\n26C233040\n26C233443\n25C227710\n26C232380\n26C233041\n26C233444\n25C227711\n26C232381\n26C233090\n26C233446\n26C233448\n26C234080\n26C234360\n26C234647\n26C233449\n26C234081\n26C234361\n26C234648\n26C233450\n26C234082\n26C234362\n26C234649\n26C233451\n26C234083\n26C234363\n26C234797\n26C233452\n26C234084\n26C234364\n26C234798\n26C233692\n26C234085\n26C234566\n26C234799\n26C233693\n26C234086\n26C234567\n26C234800\n26C233694\n26C234087\n26C234630\n26C234801\n26C233695\n26C234088\n26C234631\n26C234802\n26C233696\n26C234089\n26C234632\n26C234804\n26C233697\n26C234090\n26C234633\n26C234805\n26C233698\n26C234345\n26C234634\n26C234806\n26C233699\n26C234346\n26C234635\n26C234807\n26C233700\n26C234349\n26C234636\n26C234808\n26C233701\n26C234350\n26C234637\n26C234809\n26C234071\n26C234351\n26C234638\n26C234810\n26C234072\n26C234352\n26C234639\n26C234811\n26C234073\n26C234353\n26C234640\n26C234812\n26C234074\n26C234354\n26C234641\n26C234813\n26C234075\n26C234355\n26C234642\n26C234814\n26C234076\n26C234356\n26C234643\n26C234815\n26C234077\n26C234357\n26C234644\n26C234816\n26C234078\n26C234358\n26C234645\n26C235036\n26C234079\n26C234359\n26C234646\n26C235037\n26C235038\n26C235140\n26C235437\n26C235699\n26C235039\n26C235141\n26C235438\n26C235700\n26C235040\n26C235142\n26C235439\n26C235701\n26C235041\n26C235143\n26C235440\n26C235702\n26C235042\n26C235144\n26C235441\n26C235704\n26C235043\n26C235145\n26C235442\n26C235705\n26C235044\n26C235146\n26C235443\n26C236027\n26C235045\n26C235147\n26C235444\n26C236028\n26C235046\n26C235148\n26C235445\n26C236029\n26C235047\n26C235149\n26C235446\n26C236030\n26C235048\n26C235150\n26C235447\n26C236031\n26C235049\n26C235151\n26C235686\n26C236032\n26C235050\n26C235152\n26C235687\n26C236035\n26C235051\n26C235153\n26C235688\n26C236036\n26C235052\n26C235428\n26C235689\n26C236038\n26C235053\n26C235429\n26C235691\n26C236039\n26C235054\n26C235430\n26C235692\n26C236042\n26C235055\n26C235431\n26C235693\n26C236111\n26C235134\n26C235432\n26C235694\n26C236252\n26C235135\n26C235433\n26C235695\n26C236253\n26C235136\n26C235434\n26C235696\n26C235137\n26C235435\n26C235697\n26C235138\n26C235436\n26C235698", "firm_fei_number": "1523574", "recalling_firm": "Ferno-Washington Inc", "address_1": "70 Weil Way", "city": "Wilmington", "state": "OH", "postal_code": "45177-9371", "additional_info_contact": "DOROTHY RAMSEY\n1-937-2832885", "reason_for_recall": "Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and movement of the stretcher along the rail may no longer be possible through either powered or manual operation. May cause delays in transport of patient to healthcare facility.", "root_cause_description": "Process control", "action": "On June 19. 2026, the firm began notifying customers via Urgent Medical Device Correction letters.\n\nCustomers were instructed to contact Ferno for assistance if abnormal rail movement, increased resistance during rail extension or retraction, or other unusual rail operation is observed.\n\nFerno will contact all affected customers directly and dispatch trained field service personnel to perform the correction onsite at customer locations. The correction does not require removal of the PF2 Fastening System from service prior to the scheduled repair.\n\nThe field correction consists of replacement of the affected roller assembly with an updated assembly manufactured in accordance with revised assembly requirements intended to eliminate the potential for interference and subsequent roller deformation.", "product_quantity": "278", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, GA, IA, ID, IL, IN, KY, LA, MD, ME, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Poland, Netherlands, Canada, Germany, Norway, United Kingdom, Denmark and New Zealand.", "openfda": { "k_number": [ "K862441", "K840920", "K761147", "K943969", "K946101", "K952447", "K943864", "K972528", "K871556", "K863083", "K943528", "K902503", "K881845", "K933366", "K932260", "K961437", "K861410", "K840124", "K844578", "K873181", "K922808", "K933071", "K935297", "K923730", "K874332", "K900872", "K792570", "K843439", "K955766", "K914543", "K862959", "K864269", "K840125", "K945431", "K854304", "K884759", "K933060", "K801935", "K943529", "K904011", "K962181", "K853421", "K942948", "K920704", "K113598", "K072598", "K895740", "K943262", "K840122", "K922809" ], "registration_number": [ "3021559257", "3030927791", "3008975187", "3008042739", "3017844600", "8030903", "1528440", "3007420694", "3006513362", "3009567010", "3017708892", "3011574775", "3016678414", "3007802293", "1043549", "8022103", "3004198457", "3014270896", "3005878604", "1931947", "3011659880", "3027847726", "2428983", "3008434522", "3008058231", "3003674698", "2184033", "3007836437", "3009222501", "3042262500", "2183887", "3009171220", "3006750986", "3005706637", "1000211739", "3008881803", "3007515312", "3017181414", "3011910987", "2024242", "2020676", "3014101053", "3009238346", "3033849261", "3038197284", "3001947547", "9681454", "3017884063", "9615386", "3009688852", "1831750", "3006697241", "3007123908", "2518443", "1033902", "3045978136", "3013408788", "3006897996", "3013856565", "2027797", "3020978037", "9613910", "3006554931", "3006975482", "3003770834", "1824206", "3015223105", "3017421556", "3002818647", "3006891315", "3005206084", "1000122786", "3010509576", "3006554924", "3020460367", "3006123327", "3027332478", "3026311463", "3042991836", "3012330365", "3005070829", "3007744192", "3031582440", "3031563141", "3010703925", "3004499949", "3013964848", "3011719874", "1523574", "3038141559", "3003749961", "3043654660", "2183191", "3007912863", "3007662999", "3045752744", "3010373263", "1721113", "3011537487", "3030488262", "8010652", "8022752", "3037012186", "3006342679", "3006157842", "3007583774", "1422399", "3008386649", "3014739961" ], "fei_number": [ "3021559257", "3030927791", "1000118429", "3008975187", "3008042739", "3017844600", "3007420694", "3006513362", "3009567010", "3017708892", "3011574775", "1000122527", "3016678414", "3007802293", "1043549", "3004198457", "3014270896", "3005878604", "3011659880", "3027847726", "1000115792", "3008434522", "3008058231", "3003674698", "3007836437", "3009222501", "3042262500", "2183887", "3009171220", "3006750986", "3005706637", "1000211739", "3003769112", "3008881803", "3007515312", "3017181414", "3011910987", "1841", "2024242", "3000134760", "2020676", "3014101053", "3009238346", "3033849261", "3038197284", "3001947547", "3017884063", "3009688852", "1831750", "3006697241", "3007123908", "2518443", "1033902", "3045978136", "3013408788", "3006897996", "3013856565", "3004574120", "3020978037", "3006554931", "3006975482", "3003770834", "1824206", "3002913923", "2427360", "3015223105", "3017421556", "3002818647", "3006891315", "3005206084", "1000122786", "3010509576", "3006554924", "3020460367", "3006123327", "3027332478", "3026311463", "3042991836", "3012330365", "3005070829", "3007744192", "3031582440", "3002808508", "3031563141", "3002572935", "3010703925", "3004499949", "3013964848", "3011719874", "1523574", "3038141559", "3003749961", "3043654660", "2183191", "3007912863", "3007662999", "3045752744", "3010373263", "1721113", "3011537487", "3030488262", "1000125727", "3037012186", "3006342679", "3006157842", "1000143830", "3007583774", "3008386649", "3014739961" ], "device_name": "Stretcher, Wheeled", "medical_specialty_description": "General Hospital", "regulation_number": "880.6910", "device_class": "2" } } ] }