{"recall":{"id":"fda-device-99667","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medline Industries, LP recalls 4 products","firm":"Medline Industries, LP","date":"2026-07-31","reported":"2026-09-23","status":"Ongoing","classification":"Class II","products":[{"name":"Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A","code":"UDI-DI 10195327506506 Lot 25BBK494","quantity":"341","number":"Z-3207-2026","classification":"Class II"},{"name":"Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F","code":"DYNJ58421A UDI-DI 10193489970487 Lot 25HBQ049 DYNJ40734F UDI-DI 10198459162084 Lots 25GBO299 25IBS607","quantity":"459","number":"Z-3208-2026","classification":"Class II"},{"name":"Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A","code":"UDI-DI 10198459046551 Lot 25FBU754","quantity":"60","number":"Z-3209-2026","classification":"Class II"},{"name":"Convenience kits CATARACT PACK DYNJ59881A","code":"UDI-DI 10198459020612 Lot 25GBP246","quantity":"336","number":"Z-3210-2026","classification":"Class II"}],"reason":"Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.","nationwide":true,"states":[],"units":"341; 459; 60; 336","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=99667","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"82b2d08126f74cca","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=99667","record":[{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99667","recalling_firm":"Medline Industries, LP","address_1":"3 Lakes Dr","address_2":"N/A","postal_code":"60093-2753","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.","recall_number":"Z-3207-2026","product_description":"Convenience kits    ANESTHESIA PAIN PK LEAGUE  DYNJ67925A","product_quantity":"341","reason_for_recall":"Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.","recall_initiation_date":"20260731","center_classification_date":"20260916","report_date":"20260923","code_info":"UDI-DI 10195327506506 Lot 25BBK494","more_code_info":""},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99667","recalling_firm":"Medline Industries, LP","address_1":"3 Lakes Dr","address_2":"N/A","postal_code":"60093-2753","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.","recall_number":"Z-3208-2026","product_description":"Convenience kits    MINOR PACK\t  \tDYNJ58421A  \t  SPRINGHILL MINOR PACK\t  \tDYNJ40734F","product_quantity":"459","reason_for_recall":"Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.","recall_initiation_date":"20260731","center_classification_date":"20260916","report_date":"20260923","code_info":"DYNJ58421A    UDI-DI 10193489970487    Lot 25HBQ049          DYNJ40734F    UDI-DI 10198459162084    Lots 25GBO299   25IBS607","more_code_info":""},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99667","recalling_firm":"Medline Industries, LP","address_1":"3 Lakes Dr","address_2":"N/A","postal_code":"60093-2753","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.","recall_number":"Z-3209-2026","product_description":"Convenience kits    MYRINGOTOMY PACK-LF\t  \tDYNJ59097A","product_quantity":"60","reason_for_recall":"Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.","recall_initiation_date":"20260731","center_classification_date":"20260916","report_date":"20260923","code_info":"UDI-DI 10198459046551   Lot 25FBU754","more_code_info":""},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99667","recalling_firm":"Medline Industries, LP","address_1":"3 Lakes Dr","address_2":"N/A","postal_code":"60093-2753","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.","recall_number":"Z-3210-2026","product_description":"Convenience kits    CATARACT PACK\t  \tDYNJ59881A","product_quantity":"336","reason_for_recall":"Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.","recall_initiation_date":"20260731","center_classification_date":"20260916","report_date":"20260923","code_info":"UDI-DI 10198459020612   Lot 25GBP246","more_code_info":""}]}}