{"url_path":"/fda/device/recalls/Z-2034-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medline Kit Number/SKU DYNJ0751220P;   2. ENSEMBLE RACHIS-LF, Medline Kit Number/SKU DYNJ47568B;   3. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555B;   4. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555C;   5. UROLOGY ROBOTIC, Medline Kit…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-19","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2034-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Medline Industries, LP"},"word_count":861,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2034-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-19\n**Report date:** 2026-05-06\n\n## Product\nMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medline Kit Number/SKU DYNJ0751220P;   2. ENSEMBLE RACHIS-LF, Medline Kit Number/SKU DYNJ47568B;   3. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555B;   4. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555C;   5. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555D.\n\n## Reason\nDuring an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.\n\n## Affected lots\nMedline Kit Number/SKU DYNJ0751220P:  UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 22EMB486;  Medline Kit Number/SKU DYNJ0751220P:  UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 22CMI117;  Medline Kit Number/SKU DYNJ0751220P:  UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 22CMB218;  Medline Kit Number/SKU DYNJ0751220P:  UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 22CMB219;  Medline Kit Number/SKU DYNJ0751220P:  UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21LMA406;  Medline Kit Number/SKU DYNJ0751220P:  UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21LMA805;  Medline Kit Number/SKU DYNJ0751220P:  UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21JMF667;  Medline Kit Number/SKU DYNJ0751220P:  UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21IMF752;  Medline Kit Number/SKU DYNJ0751220P:  UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21HMG136;  Medline Kit Number/SKU DYNJ0751220P:  UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21HMB278;  Medline Kit Number/SKU DYNJ0751220P:  UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21GMD367;  Medline Kit Number/SKU DYNJ0751220P:  UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21CKA503;  Medline Kit Number/SKU DYNJ0751220P:  UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21AKA471;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23JBT331;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23IBL993;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23GBN118;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23FBQ324;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23EBO916;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23CBI861;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23BBE825;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23ABD998;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22LBA177;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22IBJ001;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22FBY332;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22FBX502;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22EBE351;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22ABO417;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21WBA306;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21KBG927;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21GBW059;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21GBW057;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21EBP877;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21EBP891;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 26ABT067;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 25LBO620;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 25LBC010;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24KBR338;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24HBS302;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24HBR212;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24FBM377;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24EBC753;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24BBN421;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24BBG081;  Medline Kit Number/SKU DYNJ47568B:  UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23LBC938;  Medline Kit Number/SKU DYNJ55555B:  UDI/DI each 10195327040284, UDI/DI case 40195327040285, Lot Number: 22ABW137;  Medline Kit Number/SKU DYNJ55555B:  UDI/DI each 10195327040284, UDI/DI case 40195327040285, Lot Number: 22ABD653;  Medline Kit Number/SKU DYNJ55555B:  UDI/DI each 10195327040284, UDI/DI case 40195327040285, Lot Number: 21LBN774;  Medline Kit Number/SKU DYNJ55555C:  UDI/DI each 10195327154738, UDI/DI case 40195327154739, Lot Number: 22IBD321;  Medline Kit Number/SKU DYNJ55555C:  UDI/DI each 10195327154738, UDI/DI case 40195327154739, Lot Number: 22HBB560;  Medline Kit Number/SKU DYNJ55555C:  UDI/DI each 10195327154738, UDI/DI case 40195327154739, Lot Number: 22GBG766;  Medline Kit Number/SKU DYNJ55555C:  UDI/DI each 10195327154738, UDI/DI case 40195327154739, Lot Number: 22DBU479;  Medline Kit Number/SKU DYNJ55555D:  UDI/DI each 10195327276041, UDI/DI case 40195327276042, Lot Number: 23KBQ339;  Medline Kit Number/SKU DYNJ55555D:  UDI/DI each 10195327276041, UDI/DI case 40195327276042, Lot Number: 23JBF048;  Medline Kit Number/SKU DYNJ55555D:  UDI/DI each 10195327276041, UDI/DI case 40195327276042, Lot Number: 23EBX527;  Medline Kit Number/SKU DYNJ55555D:  UDI/DI each 10195327276041, UDI/DI case 40195327276042, Lot Number: 23DBG858;  Medline Kit Number/SKU DYNJ55555D:  UDI/DI each 10195327276041, UDI/DI case 40195327276042, Lot Number: 23CBX731;  Medline Kit Number/SKU DYNJ55555D:  UDI/DI each 10195327276041, UDI/DI case 40195327276042, Lot Number: 23CBF699;  Medline Kit Number/SKU DYNJ55555D:  UDI/DI each 10195327276041, UDI/DI case 40195327276042, Lot Number: 22LBJ888.\n\n## Distribution\nWorldwide distribution."}