{"recall":{"id":"fda-device-99561","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medline Industries, LP recalls 13 products","firm":"Medline Industries, LP","date":"2026-07-20","reported":"2026-09-09","status":"Ongoing","classification":"Class II","products":[{"name":"Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A","code":"UDI-DI 10198459362835 Lots 25IBJ918 25KBN677 25LBU066 26BBD775","quantity":"222,653 total","number":"Z-3067-2026","classification":"Class II"},{"name":"Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB","code":"CDS983348AA UDI-DI 10195327385088 Lots 24IBK346 24JBK539; CDS983348AB UDI-DI 10198459136986 Lots 25CBF097 25HBB232 25HBB761 25HBH209 25HBU907 25JBQ176","quantity":"222,653 total","number":"Z-3068-2026","classification":"Class II"},{"name":"Medline Convenience Kits containing BD ChloraPrep Clear - 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1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP KIT DYKM1398B","code":"DYKS2018 UDI-DI 10198459188480 Lot 25GMI043 DYKS1584A UDI-DI 10198459146633 Lots 24JBA740 25ABF244 DYKS1216I UDI-DI 10198459362668 Lots 25GBP888 25JBD789 26ABL474 26CBF334 26DBD640 26EBB855 26FBC632 DYKM1398B UDI-DI 10198459413827 Lots 25HBI183 25JBK222 25KBA990 25LBJ990 26BBI525 26CBJ249 26EBQ630 26FMF189","quantity":"222,653 total","number":"Z-3074-2026","classification":"Class II"},{"name":"Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C WELCOME KIT DYKS1206D","code":"DYKA1384B UDI-DI 10198459415753 Lot 25GBS617 DYKA1384C UDI-DI 10198459485206 Lot 25IBF898 DYKS1206D UDI-DI 10198459414794 Lots 25HBI181 25JBJ452 25LBJ223 26ABT372 26CBF527 26EBH733","quantity":"222,653 total","number":"Z-3075-2026","classification":"Class II"},{"name":"Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F","code":"CDS981762B UDI-DI 10193489306767 Lots 24JBE456 24JBN932 24KBJ154 25ABK513 25CBL684 25HBK086 25IBM188 25KBL720 25LBF812 25LBU497 26ABM665 26CBH544 26CBT272 26FBK806 DYKA1054F UDI-DI 10193489312607 Lots 24ILA823 24JLA285 24LLA226 24LLB033 25BLA842 25ELA624 25GLA270 25HLB055 25KLA019 25KLA187 26BLA150 26CLA717 26DLA410 26ELA772 26FLA756","quantity":"222,653 total","number":"Z-3076-2026","classification":"Class II"},{"name":"Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP DYNJ32702B","code":"UDI-DI 10193489431070 Lots 25BBB005 25GBY063 25KBI862 25LBT688 26CBG211","quantity":"222,653 total","number":"Z-3077-2026","classification":"Class II"},{"name":"Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A","code":"DYKS1583A UDI-DI 10198459146640 Lot 24KBP388","quantity":"222,653 total","number":"Z-3078-2026","classification":"Class II"},{"name":"Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION KIT DYKM1636A","code":"UDI-DI 10889942925858 Lot 26EBI940","quantity":"222,653 total","number":"Z-3079-2026","classification":"Class II"}],"reason":"Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution.","nationwide":true,"states":[],"units":"222,653 total; 222,653 total; 222,653 total; 222,653 total; 222,653 total; 222,653 total; 222,653 total; 222,653 total; 222,653 total; 222,653 total; 222,653 total; 222,653 total; 222,653 total","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=99561","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"fcbb6c795161b0fd","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=99561","record":[{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99561","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.","recall_number":"Z-3067-2026","product_description":"Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators    PAIN PRE OP KIT\t  \tDYKS1476A","product_quantity":"222,653 total","reason_for_recall":"Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.","recall_initiation_date":"20260720","center_classification_date":"20260831","report_date":"20260909","code_info":"UDI-DI 10198459362835 Lots 25IBJ918 25KBN677 25LBU066 26BBD775","more_code_info":""},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99561","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.","recall_number":"Z-3068-2026","product_description":"Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators    OPEN HEART\t  \tCDS983348AA  \tCDS983348AB","product_quantity":"222,653 total","reason_for_recall":"Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.","recall_initiation_date":"20260720","center_classification_date":"20260831","report_date":"20260909","code_info":"CDS983348AA    UDI-DI 10195327385088    Lots 24IBK346   24JBK539;  CDS983348AB    UDI-DI 10198459136986    Lots 25CBF097   25HBB232   25HBB761   25HBH209   25HBU907   25JBQ176","more_code_info":""},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99561","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.","recall_number":"Z-3069-2026","product_description":"Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators    BASIN PACK-LF\t  \tDYNJ42828B    EYE BASIN TRAY-LF\t  \tDYNJ42832B","product_quantity":"222,653 total","reason_for_recall":"Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.","recall_initiation_date":"20260720","center_classification_date":"20260831","report_date":"20260909","code_info":"DYNJ42828B   UDI-DI 10198459425516  Lots  25GBQ173   25HBB240   25JBD028   25LBL133   26ABU673   26CBN583   26EBD855   26FBO892;    DYNJ42832B   UDI-DI 10198459425530  Lots  25LBE548   26BBG040   26CBH272   26EBC041   26FBD497","more_code_info":""},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99561","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.","recall_number":"Z-3070-2026","product_description":"Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators    BLOOD CULTURE PINK PERIPHERAL\t  \tDYNDV1875  \t  BOTTOM DRAWER\t  \tACC010972  \t\t  DRAWER #4\t  \tACC010479A\t  \t  DRAWER 2\t  \tACC010690          ACC010875    DRAWER 3 SYR/DRS/MON/NG 1 OF 3\t  \tACC011073  \t  DRAWER 4 CIRCULATION\t  \tACC011088  \t  DRAWER 5 - LEFT BOX\t  \tACC011067    LABOR TRIAGE KIT - LF #13232\t  \tDYKM1564  \t  \tDYKM1564A  \t  LINEN UNIVERSAL PACK\t  \tDYNJT10325  \t  MAC KIT\t  \tDYKS1089B  \t  NICU LINE PACK\t  \tDYNJ63410  \t  PEDIATRIC BLOOD CULTURE KIT\t  \tDYNDH1363  \t  RRMC CODE CART DRAWER 3\t  \tACC010770  \t    STANFORD TIME TO POSITIVITY\t  \tDYNDH1591\t    STUDENT PRACTICE BAG W LOGO\t  \tEDUC1043          EDUC1043A    SUTURED SHEATH W/SCI #113198\t  \tDYKM1496\t\t  \t  IV START KIT\t  \tDYNDV2520","product_quantity":"222,653 total","reason_for_recall":"Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.","recall_initiation_date":"20260720","center_classification_date":"20260831","report_date":"20260909","code_info":"DYNDV1875    UDI-DI 10888277860209    Lot 24JMB689    ACC010972    UDI-DI 10198459303289    Lots 25DDA151   25DDA401   25EDA655    ACC010479A    UDI-DI 10195327131517    Lot 25BDB620    ACC010690    UDI-DI 10195327433307    Lots 24LDB023   25BDA230   25GDA245   25JDB903   25KDB182   25LDA088   25LDA809   26ADC073   26CDA991   26DDB182   26EDA950   26EDB485   26FDB456 ACC010875    UDI-DI 10198459113659    Lots 24JDA648   25CDB776   25JDB205   25KDB028   25LDB271   26DDA182   26DDA786   26EDA629    ACC011073    UDI-DI 10198459569333    Lot 25LDA072    ACC011088    UDI-DI 10198459589577    Lots 26BDA548   26GDA090    ACC011067    UDI-DI 10198459529184    Lots 25KDA639   25LDA980   26CDB158    DYKM1564    UDI-DI 10889942754571    Lots 24HBW937   24JBX634   24LBR085   25GBH209   25IBK590   25LBD525   26ABI524   26BBM585   26DBC555 DYKM1564A    UDI-DI 10198459805165    Lot 26FBK649    DYNJT10325    UDI-DI 10198459787324    Lots 26EBM250   26FBA470   26FBF055   26FBH553   26FBH554    DYKS1089B    UDI-DI 10193489306286    Lots 24JMG846   24LMD918   25GMD759   25GMK431   25IMF050   25KMJ026   26BMC073   26DMI048    DYNJ63410    UDI-DI 10193489737431    Lots 24LDB851   25BDA890    DYNDH1363    UDI-DI 10888277795464    Lots 24IBH349   24IBS200   24JBQ160   24KBN447   24LBG380   24LBI547   25ABW563   25DBH954   25GBD824   25HBT172   25IBO192   25JBB921   25JBQ987    ACC010770    UDI-DI 10195327576998    Lots 25HDA878   25IDA087   25IDA817   25JDB317   25KDB340   25LDB061   26ADA012   26ADA159   26ADB380   26ADC072   26BDA633   26CDA678    DYNDH1591    UDI-DI 10193489497236    Lots 24JMA966   25GMD752   25LMJ154   26AME497   26BMA252   26DMI088   26EMH914   26FMH453   26FMK588    EDUC1043    UDI-DI 10195327425531    Lots 24KDA258   24KDA880   24KDA963    EDUC1043A    UDI-DI 10198459334559    Lots 25FLA817   25GLA090   25KLA077   25KLA693   26CLB165   26CLB165Z   26ELA472  DYKM1496    UDI-DI 10889942636082    Lot 24KBL243       DYNDV2520    UDI-DI 10653160384045    Lot 2024111990","more_code_info":""},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99561","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.","recall_number":"Z-3071-2026","product_description":"Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators    IV START KIT LAB DRAW-SH\t  \tCDS860014Q    IV START KIT\t  \tDYKM1000B    IV START KIT LAB DRAW-SH\t  \tCDS860014P    ULTRASOUND GUIDED PIV START KI\t  \tDYNDV2684","product_quantity":"222,653 total","reason_for_recall":"Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. 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