{ "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": "214975", "product_res_number": "Z-2331-2025", "event_date_initiated": "2025-06-27", "event_date_posted": "2025-08-15", "recall_status": "Open, Classified", "res_event_number": "97229", "product_code": "GDM", "product_description": "Injection needle, bayonet, Luer-Lock,\r\n\r\n1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile;\r\n\r\n2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile", "code_info": "1. Model No 50-353-23; UDI-DI 04250381858806; LOT (0)2241239\n2. Model No 50-345-23; UDI-DI 04250381858813; LOT 2230438; LOT 2240251", "firm_fei_number": "3002858762", "recalling_firm": "Spiggle & Theis Mt Gmbh", "address_1": "Lagerstr. 11 11 lagerstr.", "city": "Dieburg", "country": "Germany", "reason_for_recall": "Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.", "root_cause_description": "Under Investigation by firm", "action": "On June 27, 2025, the firm notified customers through a letter titled \"Urgent safety information Recall Injection Needle\". Customers were asked to identify and quarantine any affected product in stock. Customer service will assist customers in returning product and the firm will issue a credit upon receipt of the affected product.", "distribution_pattern": "US Nationwide distribution in the states of California, Connecticut, Missouri, and Ohio.", "openfda": { "k_number": [ "K854420", "K870523", "K862749", "K843690", "K902177", "K903750", "K883876", "K953082", "K903749", "K895594", "K841299", "K830235", "K923872", "K881624", "K874928", "K862805", "K895752", "K936207", "K843830", "K864193", "K903747", "K071732", "K882073", "K880812", "K772293", "K862481", "K882240", "K800406", "K915572", "K891537", "K881783", "K833720", "K904667", "K903748", "K953064", "K820339", "K882601", "K873848", "K881730", "K881784", "K901995", "K885283", "K895551", "K971114", "K930160", "K771574", "K791643", "K890722" ], "device_name": "Needle, Aspiration And Injection, Reusable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4800", "device_class": "1", "registration_number": [ "3005064943", "9610849", "2243072", "3024988980", "1625425", "3012494290", "3016248634", "3022748632", "8040278", "2953359", "3030839824", "8044098", "2030580", "2521453", "3005528784", "3014615697", "9617768", "1926681", "3002858762", "3013497507", "1417485", "1836161", "3011600579", "3023339277", "9680837", "1424263", "1920664", "2916714", "3007597038", "1646747", "1421879", "3008843439", "3015143057", "2434839", "3008514120", "1649660", "3003761012", "3005987240", "2029015", "3032109", "3005440795", "9710524", "9615004", "3014761220", "3003431869", "3003807268", "1929756", "9612074", "3004111573", "3033536312", "3008797953", "3003687489", "3032747418", "9610612", "3009255580", "1211566", "1932180", "1720747", "3013055489", "3006611221", "9611102", "1417592", "1220477", "2529846", "9615857", "3013557562", "1644312", "9611610", "8010099", "8010877", "1450662", "3011050570", "3009513193", "3012507533", "8040233", "3003418325", "3035708926", "3040389299", "1421101", "2011171", "1045379", "3003244954", "5906", "3004365956", "2126670", "3004215117", "9680515", "1423507", "3006897996", "2020550", "9680718", "3010197239", "3012267976", "9612278", "3007137643", "2511556", "3010041511", "3043355002", "3004608878", "9616250", "8010257", "3011137372", "9611112", "3008770252", "8043368", "1313525", "1828424", "3004001706", "9611516", "3011387885", "9611283", "2085199", "1056350", "3010202439" ], "fei_number": [ "3003499455", "3005064943", "5870", "1000140363", "1000246164", "2243072", "1000117748", "3024988980", "3000215205", "1000115048", "1625425", "3012494290", "3002807072", "3016248634", "3022748632", "1000194896", "3003944071", "1000160732", "3030839824", "3001451796", "3002807391", "2521453", "3002750084", "3005528784", "3014615697", "4498", "3008002452", "3003772581", "3001238683", "1926681", "1317628", "3002858762", "3013497507", "1417485", "3011600579", "3002807634", "3023339277", "3008782585", "1920664", "2916714", "3001130644", "3008843439", "3015143057", "3005747797", "3002806862", "2434839", "3008514120", "3003761012", "3002806816", "3005987240", "3005440795", "3014761220", "3942", "3003431869", "3003807268", "1000160162", "3002808001", "1929756", "3002806863", "3004111573", "3033536312", "3008797953", "3002806315", "3003687489", "3032747418", "3003249645", "1000347621", "3005969827", "3004028763", "3009255580", "1211566", "1720747", "1000160458", "3013055489", "1417592", "3004216008", "1220477", "3002409980", "3013557562", "3007475226", "1450662", "3011050570", "3009513193", "3012507533", "3003015552", "3000280067", "1000136191", "3003418325", "3035708926", "3040389299", "1421101", "2011171", "1045379", "3003244954", "5906", "3004365956", "2126670", "3002807264", "3004215117", "3006897996", "2020550", "3010197239", "3012267976", "1000119305", "3007137643", "2511556", "3010041511", "3043355002", "3004608878", "3008770252", "1828424", "3004001706", "3011387885", "1000518699" ] } } ] }