{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "195753", "product_res_number": "Z-0020-2023", "event_date_initiated": "2022-07-29", "event_date_posted": "2022-10-07", "recall_status": "Open, Classified", "res_event_number": "90769", "product_code": "FBK", "k_numbers": [ "K834403" ], "product_description": "Hobbs Posi-Stop Injection Needle\n\nCatalog Number: 4702", "code_info": "UDI-DI:M84947020\n \nLot Numbers:\nH10-17-062R\nH10-17-062R", "firm_fei_number": "1220592", "recalling_firm": "Hobbs Medical, Inc.", "address_1": "8 Spring St", "city": "Stafford Springs", "state": "CT", "postal_code": "06076-1505", "additional_info_contact": "Hobbs Medical Customer Service\n800-344-6227", "reason_for_recall": "Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)", "root_cause_description": "Process control", "action": "Hobbs Medical issued URGENT RECALL letter via Certified Mail with return receipt requested on 7/29/22. Letter states reason for recall, health risk and action to take:\n1. Read the Description of the problem section.\n2. Immediately identify and set aside all product listed herein in a manner that ensures the affected product will not be used and will be returned to Hobbs Medical.\n3. Review, complete, and return the enclosed Acknowledgement Form directly to Hobbs\nMedical Customer Service, return via Fax at 860-684-7574, or email to\nCustomerService@HobbsMedical.com.\n4. Pass on this notice to anyone in your facility that needs to be informed according to\nyour internal notification procedures.\n5. If any product listed below has been forwarded to another facility, contact that facility\nto arrange return.\n6. Maintain awareness of this notice until all product listed above has been returned to\nHobbs Medical.\n\nFor questions related to the issue, the Acknowledgement form, and product replacement,\nplease contact Hobbs Medical Customer Service at:\n1-800-344-6227\nCustomerService@hobbsmedical.com\nReturn instructions are provided on the Acknowledgement Form", "product_quantity": "8 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.", "openfda": { "k_number": [ "K961846", "K954519", "K111495", "K950976", "K990996", "K190032", "K924102", "K001146", "K232200", "K960519", "K061222", "K955558", "K151475", "K220292", "K082319", "K812057", "K002323", "K113634", "K192498", "K190829", "K983765", "K212668", "K820973", "K172227", "K051905", "K241595", "K914496", "K022484", "K010448", "K241523", "K152035", "K902736", "K043383", "K180214", "K953441", "K042882", "K941305", "K011484", "K181690", "K121337", "K982890", "K903668", "K213239", "K901437", "K213914", "K865086", "K855176", "K090830", "K092090", "K232826", "K896424", "K012977", "K894868", "K210917", "K013712", "K240675", "K153625", "K133148", "K030451", "K171454", "K921800", "K221085", "K933815", "K253598", "K000646", "K252021", "K872060", "K221054", "K142144", "K091391", "K002573", "K031238", "K132065", "K222006", "K851952", "K171602", "K951648", "K002778", "K834403", "K090217", "K150434", "K260262", "K953338", "K230925", "K050688", "K883093", "K232442", "K252247", "K042615" ], "registration_number": [ "3004837686", "3008048800", "1828424", "3027269340", "3017390965", "3017178358", "3011146996", "3035451914", "9681260", "3006750742", "3005099803", "3015142721", "1722746", "3025311469", "3030447506", "3007695959", "9680809", "3012649202", "3017448360", "3043141270", "3003814961", "3008693678", "9610614", "3002647932", "1721676", "3011270181", "1000393132", "3010515547", "3000279801", "3004207966", "1220592", "3014769442", "3021632375", "3014342096", "3012480535", "3035434483", "3014620201", "3006621103", "1037905", "3015042209", "8010047", "3008797804", "1825146", "9680001", "2134494", "1222168", "1000121056", "3010273872", "1056129", "1643817", "3004129994", "3010288205", "1528319", "3005580113", "2020550", "3010202439", "3004784537", "3010419931", "1647149", "2246552", "3008274780", "3013440400", "1047843", "3011193403", "3021023752", "1519132", "2183446", "3009888344", "3011050570", "3012042439", "3015895045", "3009747810", "3011707784", "3005987240", "9610711", "3010188783", "3027454635", "3007699067", "3005941719", "1061927", "3018116884", "3013460719", "3008040402", "1018233", "3003790304", "3007156625", "3010707607", "9614641", "9610617", "3013526170", "3004083736", "3017262662", "3013023255", "3015972753", "2431166", "3008573567", "3009064553", "1820334" ], "fei_number": [ "3004837686", "3008048800", "1828424", "3027269340", "3017390965", "3017178358", "3011146996", "3035451914", "3006750742", "3005099803", "3015142721", "3025311469", "3030447506", "3007695959", "3012649202", "3002806565", "3017448360", "3043141270", "3003814961", "3008693678", "3008133910", "3002808268", "3002647932", "1000122656", "1721676", "2523865", "3011270181", "3002619738", "1000393132", "3002808445", "3010515547", "3000279801", "3004207966", "3000203000", "1220592", "3014769442", "3021632375", "3014342096", "3012480535", "3035434483", "3014620201", "3006621103", "1037905", "3015042209", "3008797804", "1825146", "1000306139", "3002807917", "1000306216", "1222168", "1000121056", "3007475226", "3010273872", "3003995201", "1643817", "3004129994", "3010288205", "3005580113", "2020550", "3004784537", "3010419931", "2246552", "3008274780", "3013440400", "1047843", "3011193403", "3021023752", "1519132", "2183446", "3009888344", "3011050570", "3012042439", "3015895045", "3009747810", "3011707784", "3002806920", "3005987240", "3002995060", "3010188783", "3027454635", "3007699067", "3018116884", "3013460719", "3008040402", "3002807795", "1018233", "3003790304", "3010707607", "3002807111", "3013526170", "3004083736", "3017262662", "1000132436", "3013023255", "3015972753", "3008573567", "3009064553", "1820334" ], "device_name": "Endoscopic Injection Needle, Gastroenterology-Urology", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }