{"recall":{"id":"fda-device-99758","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"AVID Medical, Inc. recalls 4 products","firm":"AVID Medical, Inc.","date":"2026-08-10","reported":"2026-09-23","status":"Ongoing","classification":"Class I","products":[{"name":"Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;","code":"Model/Item Number (Kit): DPGE002-02; UDI-DI: 10809160410325; Kit Lots: 1641713, 1641714, 1659697, 1668209; Recalled Sodium Chloride Ampule Lot: AB4003;","quantity":"1640 kits","number":"Z-3151-2026","classification":"Class I"},{"name":"Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;","code":"Model/Item Number (Kit): BMCN001-05; UDI-DI: 10809160455128; Kit Lots: 1703122, 1707656, 1708053; Recalled Sodium Chloride Ampule Lot: AB5002;","quantity":"80 kits","number":"Z-3152-2026","classification":"Class I"},{"name":"Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;","code":"Model/Item Number (Kit): PM415; UDI-DI: 10809160322154; Kit Lots: 1652485, 1656642, 1667835, 1676219, 1682251, 1691940; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;","quantity":"240 kits","number":"Z-3153-2026","classification":"Class I"},{"name":"Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;","code":"Model/Item Number (Kit): VARV042-03; UDI-DI: 10809160490822; Kit Lots: 1668365, 1668366, 1688166, 1692637, 1696930; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;","quantity":"340 kits","number":"Z-3154-2026","classification":"Class I"}],"reason":"Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"Domestic: IL, NC, VA, WY;","nationwide":false,"states":["IL","NC","VA","WY"],"units":"1640 kits; 80 kits; 240 kits; 340 kits","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99758","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"a3248f59467804fc","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99758","record":[{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99758","recalling_firm":"AVID Medical, Inc.","address_1":"9000 Westmont Dr","address_2":"N/A","postal_code":"23168-9351","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Domestic: IL, NC, VA, WY;","recall_number":"Z-3151-2026","product_description":"Haylard 18G SINGLE SHOT EPI TRAY;   Model/Item Number (Kit): DPGE002-02;","product_quantity":"1640 kits","reason_for_recall":"Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.","recall_initiation_date":"20260810","center_classification_date":"20260916","report_date":"20260923","code_info":"Model/Item Number (Kit): DPGE002-02; UDI-DI: 10809160410325; Kit Lots: 1641713, 1641714, 1659697, 1668209; Recalled Sodium Chloride Ampule Lot: AB4003;","more_code_info":""},{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99758","recalling_firm":"AVID Medical, Inc.","address_1":"9000 Westmont Dr","address_2":"N/A","postal_code":"23168-9351","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Domestic: IL, NC, VA, WY;","recall_number":"Z-3152-2026","product_description":"Haylard CONTINUOUS NERVE BLOCK TRAY;   Model/Item Number (Kit): BMCN001-05;","product_quantity":"80 kits","reason_for_recall":"Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.","recall_initiation_date":"20260810","center_classification_date":"20260916","report_date":"20260923","code_info":"Model/Item Number (Kit): BMCN001-05; UDI-DI: 10809160455128; Kit Lots: 1703122, 1707656, 1708053; Recalled Sodium Chloride Ampule Lot: AB5002;","more_code_info":""},{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99758","recalling_firm":"AVID Medical, Inc.","address_1":"9000 Westmont Dr","address_2":"N/A","postal_code":"23168-9351","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Domestic: IL, NC, VA, WY;","recall_number":"Z-3153-2026","product_description":"Haylard BASIC BIOPSY TRAY;   Model/Item Number (Kit): PM415;","product_quantity":"240 kits","reason_for_recall":"Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.","recall_initiation_date":"20260810","center_classification_date":"20260916","report_date":"20260923","code_info":"Model/Item Number (Kit): PM415; UDI-DI: 10809160322154; Kit Lots: 1652485, 1656642, 1667835, 1676219, 1682251, 1691940; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;","more_code_info":""},{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99758","recalling_firm":"AVID Medical, Inc.","address_1":"9000 Westmont Dr","address_2":"N/A","postal_code":"23168-9351","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Domestic: IL, NC, VA, WY;","recall_number":"Z-3154-2026","product_description":"Haylard UNIV IMAGING BIOPSY TRUCUSTOM;   Model/Item Number (Kit): VARV042-03;","product_quantity":"340 kits","reason_for_recall":"Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.","recall_initiation_date":"20260810","center_classification_date":"20260916","report_date":"20260923","code_info":"Model/Item Number (Kit): VARV042-03; UDI-DI: 10809160490822; Kit Lots: 1668365, 1668366, 1688166, 1692637, 1696930; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;","more_code_info":""}]}}