{ "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": 2 } }, "results": [ { "cfres_id": "194307", "product_res_number": "Z-1506-2022", "event_date_initiated": "2022-06-10", "event_date_created": "2022-08-05", "recall_status": "Open, Classified", "res_event_number": "90224", "product_code": "MEG", "product_description": "HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch needle}\n200 pieces/box.\nIntended Use: Disposable sterile needle retractable safety syringe.\nCatalog Number: NRSS1-25G25", "code_info": "Lot Number: 20IB0\nExp. Date: 2025/09/04", "firm_fei_number": "3010596027", "recalling_firm": "Guangdong Haiou Medical Apparatus Co., Ltd", "address_1": "Nanyuan Industrial Zone North Liusha", "city": "Puning", "country": "China", "additional_info_contact": "SAME\n663-2930777", "reason_for_recall": "Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an increased risk of needle stick injury to the end user", "root_cause_description": "No Marketing Application", "action": "Guangdong Haiou Medical., LTD (Haiou) contacted direct consignee by\nemail on [10-Jun-2022] and Formal Recall Urgent Medical Device Recall letter through email and first-class letter. Letter states reason for recall, health risk and action to take:\n\" Remove product from sale and cease distribution of product subject to this recall action.\n\" Immediately review your inventory for the specific Product Description and Lot Number listed above and place into quarantine until further notice.\n\" Notify us of any stock you have still under your direct control\n\" Notify all customers to whom you have distributed this product of this recall. Use the\ntemplate provided with this letter.\n\" Complete the attached Customer Response Form and return to the Haiou contact noted on the form whether or not you have any of the impacted material so that Haiou may\nacknowledge your receipt of this notification per FDA requirements and subsequently\nprocess your product replacement.\n\" Forward any customer complaints for the use of this product to Haiou as per the contact information provided.\n\nJiehong Luo QA Manager Phone:+ 86-663-2900999\nEmail: qc@haiou.net.cn\nAddress: Nanyuan Industrial Zone,\nNorth Liusha, Puning City, Guangdong, China", "product_quantity": "4,050,000 units", "distribution_pattern": "US Nationwide distribution in the state of CA.", "openfda": { "k_number": [ "K152808", "K041970", "K150562", "K933569", "K213077", "K101233", "K231165", "K210229", "K220114", "K050116", "K061194", "K993996", "K062780", "K070203", "K221981", "K141349", "K051762", "K173743", "K980069", "K142435", "K221073", "K060743", "K031830", 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