{"recall":{"id":"fda-device-99329","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":"2026-06-11","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.","code":"Medline Kit SKU DYNJ910103B, UDI/DI 10198459346873 (each) 40198459346874 (case), Lot Number 25FBR237; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25ABM761; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25BBD107; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBD534; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBL772.","quantity":"155 kits","number":"Z-2788-2026","classification":"Class II"},{"name":"Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK, Medline Kit SKU DYNJ88566; 3) MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535.","code":"Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25GBE239; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 24LBF187; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25ABM992; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25CBJ129; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25DBI743; Medline Kit SKU DYNJ88566, UDI/DI 10198459179235 (each) 40198459179236 (case), Lot Number 24KBK487; Medline Kit SKU DYNJ911535, UDI/DI 10198459377600 (each) 40198459377601 (case), Lot Number 25FBU802.","quantity":"398 kits","number":"Z-2789-2026","classification":"Class II"},{"name":"Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397P","code":"UDI/DI 10198459098109 (each) 40198459098100 (case), Lot Numbers: 25AMJ225, 25CMF838, 24KME164, 25DMB248, 25FMD941, 25GMB662, 25GMG296.","quantity":"574 kits","number":"Z-2790-2026","classification":"Class II"},{"name":"Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU DYNJ65065A: 2) EXTREMITY/FOOT PACK Medline Kit SKU DYNJ65066B: 3) ANTERIOR CERVICAL-SMH Medline Kit SKU DYNJ907718B: 4) LAMINECTOMY-SMH Medline Kit SKU DYNJ907732C: 5) KYPHOPLASTY Medline Kit SKU DYNJ907984C: 6) LUMBAR LAMINECTOMY Medline Kit SKU DYNJ907987D: 7) KYPHOPLASTY TRAY Medline Kit SKU DYNJ908413C: 8) CRANIOTOMY Medline Kit SKU DYNJ910626: 9) NEURO SPINE Medline Kit SKU DYNJ910639.","code":"Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 24KMI926; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25BMI009; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25DME458; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25FMC143; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 24KME109; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 24LMD416; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25BMB162; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25DMB403; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25DMK347; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25FMA695; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25ABJ808; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25ABM644; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25BBT262; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 24LBD661; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25ABP134; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25BBS412; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25DBS673; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25FBS372; Medline Kit SKU DYNJ907984C, UDI/DI 10198459130977 (each) 40198459130978 (case), Lot Number 25CBO351; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 24LBO744; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25ABD265; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25CBD596; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25CBO352; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25EBB260; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25EBV317; Medline Kit SKU DYNJ908413C, UDI/DI 10198459320491 (each) 40198459320492 (case), Lot Number 25EBD582; Medline Kit SKU DYNJ908413C, UDI/DI 10198459320491 (each) 40198459320492 (case), Lot Number 25FBM835; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25DBC117; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25DBE196; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25FBL400; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 24LBD222; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 24LBN441; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25ABL748; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25EBF179; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25FBF363.","quantity":"1601 units","number":"Z-2791-2026","classification":"Class II"}],"reason":"Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US:  CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.","nationwide":false,"states":["CT","FL","KS","MA","MD","MT","NY","OH","OR","VA"],"units":"155 kits; 398 kits; 574 kits; 1601 units","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=99329","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"b24eacacdddd8095","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=99329","record":[{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99329","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":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"US:  CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.","recall_number":"Z-2788-2026","product_description":"Medline medical convenience kits labeled as:    1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B;   2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.","product_quantity":"155 kits","reason_for_recall":"Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.","recall_initiation_date":"20260611","center_classification_date":"20260723","report_date":"20260729","code_info":"Medline Kit SKU DYNJ910103B, UDI/DI 10198459346873 (each) 40198459346874 (case), Lot Number 25FBR237;  Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25ABM761;  Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25BBD107;  Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBD534;  Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBL772."},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99329","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":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"US:  CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.","recall_number":"Z-2789-2026","product_description":"Medline medical convenience kits labeled as:    1) SHOULDER PACK, Medline Kit SKU DYNJ39590O;   2) SHOULDER PACK, Medline Kit SKU DYNJ88566;   3) MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535.","product_quantity":"398 kits","reason_for_recall":"Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.","recall_initiation_date":"20260611","center_classification_date":"20260723","report_date":"20260729","code_info":"Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25GBE239;  Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 24LBF187;  Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25ABM992;  Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25CBJ129;  Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25DBI743;  Medline Kit SKU DYNJ88566, UDI/DI 10198459179235 (each) 40198459179236 (case), Lot Number 24KBK487;  Medline Kit SKU DYNJ911535, UDI/DI 10198459377600 (each) 40198459377601 (case), Lot Number 25FBU802."},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99329","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":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"US:  CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.","recall_number":"Z-2790-2026","product_description":"Medline medical convenience kits labeled as:    NEURO PACK, Medline Kit SKU DYNJ59397P","product_quantity":"574 kits","reason_for_recall":"Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.","recall_initiation_date":"20260611","center_classification_date":"20260723","report_date":"20260729","code_info":"UDI/DI 10198459098109 (each) 40198459098100 (case), Lot Numbers:  25AMJ225, 25CMF838, 24KME164, 25DMB248, 25FMD941, 25GMB662, 25GMG296."},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99329","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":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"US:  CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.","recall_number":"Z-2791-2026","product_description":"Medline medical convenience kits labeled as:    1) TOTAL JOINT PACK Medline Kit SKU DYNJ65065A:   2) EXTREMITY/FOOT PACK Medline Kit SKU DYNJ65066B:   3) ANTERIOR CERVICAL-SMH Medline Kit SKU DYNJ907718B:   4) LAMINECTOMY-SMH Medline Kit SKU DYNJ907732C:   5) KYPHOPLASTY Medline Kit SKU DYNJ907984C:   6) LUMBAR LAMINECTOMY Medline Kit SKU DYNJ907987D:   7) KYPHOPLASTY TRAY Medline Kit SKU DYNJ908413C:   8) CRANIOTOMY Medline Kit SKU DYNJ910626:   9) NEURO SPINE Medline Kit SKU DYNJ910639.","product_quantity":"1601 units","reason_for_recall":"Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.","recall_initiation_date":"20260611","center_classification_date":"20260723","report_date":"20260729","code_info":"Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 24KMI926;  Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25BMI009;  Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25DME458;  Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25FMC143;  Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 24KME109;  Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 24LMD416;  Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25BMB162;  Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25DMB403;  Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25DMK347;  Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25FMA695;  Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25ABJ808;  Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25ABM644;  Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25BBT262;  Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 24LBD661;  Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25ABP134;  Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25BBS412;  Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25DBS673;  Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25FBS372;  Medline Kit SKU DYNJ907984C, UDI/DI 10198459130977 (each) 40198459130978 (case), Lot Number 25CBO351;  Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 24LBO744;  Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25ABD265;  Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25CBD596;  Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25CBO352;  Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25EBB260;  Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25EBV317;  Medline Kit SKU DYNJ908413C, UDI/DI 10198459320491 (each) 40198459320492 (case), Lot Number 25EBD582;  Medline Kit SKU DYNJ908413C, UDI/DI 10198459320491 (each) 40198459320492 (case), Lot Number 25FBM835;  Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25DBC117;  Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25DBE196;  Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25FBL400;  Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 24LBD222;  Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 24LBN441;  Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25ABL748;  Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25EBF179;  Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25FBF363."}]}}