{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 7 } }, "results": [ { "cfres_id": "219931", "product_res_number": "Z-2231-2026", "event_date_initiated": "2026-04-10", "event_date_posted": "2026-05-28", "recall_status": "Open, Classified", "res_event_number": "98837", "product_code": "CAI", "product_description": "Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: \n1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A; \n2) SPINAL ANESTHESIA TRAY, Medline SKU DYNJRA2151.", "code_info": "Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 26CBA272; \nMedline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 26ABS307; \nMedline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25HBE663; \nMedline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25FBA408; \nMedline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25CBG043; \nMedline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 24FBT395; \nMedline SKU DYNJRA2151: UDI/DI 10195327365400 each, FI case, Lot Numbers: 24FBT396.", "firm_fei_number": "1417592", "recalling_firm": "Medline Industries, LP", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Haley Barclay\n800-359-1704", "reason_for_recall": "Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.", "root_cause_description": "Component design/selection", "action": "Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 4/10/2026 via USPS first class mail and email. The notice explained the issue with the component and requested the following: \n - Identify and quarantine the affected item and lot numbers (kit). \n - Respond to notice via the portal: Website link: https://recalls.medline.com, Recall Reference #: R-26-065-FGX1, using the Recall Code provided.\n - Once the response is received, over-labels will be provided to be placed on the affected inventory with instructions to remove and discard the affected component. \n - Distributors or those who have further distributed the product are directed to notify those to whom the affected kits were distributed and include the customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. \nFor questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.", "product_quantity": "1100 kits", "distribution_pattern": "Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.", "openfda": { "k_number": [ "K770286", "K861438", "K952020", "K942136", "K930252", "K852316", "K932192", "K884072", "K813382", "K832453", "K790115", "K821086", "K910896", "K932708", "K932579", "K891479", "K812624", "K833478", "K931487", "K932576", "K770549", "K811858", "K932562", "K871386", "K840056", "K945314", "K853342", "K932558", "K780044", "K942131", "K932196", "K944429", "K932195", "K932485", "K771134", "K896365", "K870859", "K933641", "K952019", "K821087", "K771034", "K864588", "K932559", "K852632", "K935044", "K952009", "K852315", "K823714", "K942570", "K932590", 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"Circuit, Breathing (W Connector, Adaptor, Y Piece)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5240", "device_class": "1" } } ] }