{"url_path":"/fda/device/recalls/Z-2026-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:    1. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ0532910L;   2. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ39461J;   3. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060I;   4. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060J;   5. NEURO BASIN KIT, Medline Kit Number…","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-2026-2026%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":1009,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2026-2026\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. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ0532910L;   2. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ39461J;   3. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060I;   4. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060J;   5. NEURO BASIN KIT, Medline Kit Number/SKU DYNJ80200B;   6. NEURO-SPINE BASIN PACK, Medline Kit Number/SKU DYNJ83019;   7. ENT PACK, Medline Kit Number/SKU DYNJ86328;   8. EDMOND SPINE PACK, Medline Kit Number/SKU DYNJ89263;   9. ENT PACK, Medline Kit Number/SKU DYNJ89675;   10. ENT PACK, Medline Kit Number/SKU DYNJ89675A;   11. ENT/PAIN PACK, Medline Kit Number/SKU DYNJT7493.\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 DYNJ0532910L:  UDI/DI each 10198459503870, UDI/DI case 40198459503871, Lot Number: 25IMD003;  Medline Kit Number/SKU DYNJ0532910L:  UDI/DI each 10198459503870, UDI/DI case 40198459503871, Lot Number: 25HMH643;  Medline Kit Number/SKU DYNJ39461J:  UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 22GBS127;  Medline Kit Number/SKU DYNJ39461J:  UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 22FBB472;  Medline Kit Number/SKU DYNJ39461J:  UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25FBE752;  Medline Kit Number/SKU DYNJ39461J:  UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25EBA260;  Medline Kit Number/SKU DYNJ39461J:  UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25DBG176;  Medline Kit Number/SKU DYNJ39461J:  UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25CBD819;  Medline Kit Number/SKU DYNJ39461J:  UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25BBA593;  Medline Kit Number/SKU DYNJ39461J:  UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 24KBJ163;  Medline Kit Number/SKU DYNJ58060I:  UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23KMI415;  Medline Kit Number/SKU DYNJ58060I:  UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23JMK023;  Medline Kit Number/SKU DYNJ58060I:  UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23JMB211;  Medline Kit Number/SKU DYNJ58060I:  UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23IMC591;  Medline Kit Number/SKU DYNJ58060I:  UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23HMG291;  Medline Kit Number/SKU DYNJ58060I:  UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23GMG136;  Medline Kit Number/SKU DYNJ58060I:  UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23FME285;  Medline Kit Number/SKU DYNJ58060I:  UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23EME227;  Medline Kit Number/SKU DYNJ58060I:  UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23CMD903;  Medline Kit Number/SKU DYNJ58060I:  UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24KMI915;  Medline Kit Number/SKU DYNJ58060I:  UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24KMH419;  Medline Kit Number/SKU DYNJ58060I:  UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24JMG571;  Medline Kit Number/SKU DYNJ58060I:  UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24HMF066;  Medline Kit Number/SKU DYNJ58060I:  UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24FMG130;  Medline Kit Number/SKU DYNJ58060I:  UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24CMI441;  Medline Kit Number/SKU DYNJ58060I:  UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24BMD229;  Medline Kit Number/SKU DYNJ58060I:  UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24AMH016;  Medline Kit Number/SKU DYNJ58060J:  UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 26BMB944;  Medline Kit Number/SKU DYNJ58060J:  UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 26AMJ197;  Medline Kit Number/SKU DYNJ58060J:  UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25KMC587;  Medline Kit Number/SKU DYNJ58060J:  UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25JMD275;  Medline Kit Number/SKU DYNJ58060J:  UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25IMC944;  Medline Kit Number/SKU DYNJ58060J:  UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25GMF811;  Medline Kit Number/SKU DYNJ58060J:  UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25FME706;  Medline Kit Number/SKU DYNJ58060J:  UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25EMA516;  Medline Kit Number/SKU DYNJ58060J:  UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25CME296;  Medline Kit Number/SKU DYNJ58060J:  UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 24LMD726;  Medline Kit Number/SKU DYNJ80200B:  UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 22HBH553;  Medline Kit Number/SKU DYNJ80200B:  UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 26BBF722;  Medline Kit Number/SKU DYNJ80200B:  UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25JBB835;  Medline Kit Number/SKU DYNJ80200B:  UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25EBO944;  Medline Kit Number/SKU DYNJ80200B:  UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25EBL998;  Medline Kit Number/SKU DYNJ80200B:  UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25EBH356;  Medline Kit Number/SKU DYNJ80200B:  UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25EBF751;  Medline Kit Number/SKU DYNJ80200B:  UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25DBB435;  Medline Kit Number/SKU DYNJ80200B:  UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25BBC547;  Medline Kit Number/SKU DYNJ80200B:  UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 24KBR868;  Medline Kit Number/SKU DYNJ80200B:  UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 24JBV969;  Medline Kit Number/SKU DYNJ83019:  UDI/DI each 10195327228842, UDI/DI case 40195327228843, Lot Number: 23BBB952;  Medline Kit Number/SKU DYNJ83019:  UDI/DI each 10195327228842, UDI/DI case 40195327228843, Lot Number: 23BBC125;  Medline Kit Number/SKU DYNJ83019:  UDI/DI each 10195327228842, UDI/DI case 40195327228843, Lot Number: 22JBR211;  Medline Kit Number/SKU DYNJ86328:  UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25LBS635;  Medline Kit Number/SKU DYNJ86328:  UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25KBE004;  Medline Kit Number/SKU DYNJ86328:  UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25HBR489;  Medline Kit Number/SKU DYNJ86328:  UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25FBL484;  Medline Kit Number/SKU DYNJ86328:  UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25DBD392;  Medline Kit Number/SKU DYNJ86328:  UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25ABD635;  Medline Kit Number/SKU DYNJ86328:  UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 24KBB462;  Medline Kit Number/SKU DYNJ86328:  UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 24JBE518;  Medline Kit Number/SKU DYNJ86328:  UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 24GBE890;  Medline Kit Number/SKU DYNJ89263:  UDI/DI each 10198459253348, UDI/DI case 40198459253349, Lot Number: 25BBK629;  Medline Kit Number/SKU DYNJ89675:  UDI/DI each 10198459281693, UDI/DI case 40198459281694, Lot Number: 25CME067;  Medline Kit Number/SKU DYNJ89675A:  UDI/DI each 10198459417436, UDI/DI case 40198459417437, Lot Number: 26AMG054;  Medline Kit Number/SKU DYNJ89675A:  UDI/DI each 10198459417436, UDI/DI case 40198459417437, Lot Number: 26AMA771;  Medline Kit Number/SKU DYNJ89675A:  UDI/DI each 10198459417436, UDI/DI case 40198459417437, Lot Number: 25GME903;  Medline Kit Number/SKU DYNJT7493:  UDI/DI each 10198459626258, UDI/DI case 40198459626259, Lot Number: 26ABA254.\n\n## Distribution\nWorldwide distribution."}