{"url_path":"/fda/device/recalls/Z-2037-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:   1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A;   2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B;   3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A;   4. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572B;   5. MICROSURGERY PACK, Medline Kit Number/SKU DY…","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-2037-2026%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":1364,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2037-2026\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. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A;   2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B;   3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A;   4. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572B;   5. MICROSURGERY PACK, Medline Kit Number/SKU DYNJ67284A;   6. BASIC EYE PACK, Medline Kit Number/SKU DYNJ81411A;   7. SMR SINUS PACK, Medline Kit Number/SKU DYNJ84478;   8. FESS/SEPTO PACK, Medline Kit Number/SKU DYNJ85025;   9. PLASTIC EYE PACK, Medline Kit Number/SKU DYNJ89030;   10. NEURO, Medline Kit Number/SKU DYNJ902935K;   11. OCULAR, Medline Kit Number/SKU DYNJ909065;   12. OCULAR, Medline Kit Number/SKU DYNJ909065A.\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 DYNJ48725A:  UDI/DI each 10193489853896, UDI/DI case 40193489853897, Lot Number: 24IMG757;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 22FME241;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 22DMC340;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21JMC829;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21IMC497;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21HMD139;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21GME747;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21FMA440;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21DBU602;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21CBJ936;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23IBC227;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23FBA458;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23DBC239;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23ABI841;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22IBP260;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22IBO842;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22IBN801;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22GBL794;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 24HBB998;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 24DBQ664;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 24CBQ260;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 26ABC645;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25LBB014;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25JBM975;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25HBN493;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25GBM010;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25FBJ206;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25CBN002;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25ABF979;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25ABA086;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 24JBE583;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 24JBG667;  Medline Kit Number/SKU DYNJ67284A:  UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 25KBQ749;  Medline Kit Number/SKU DYNJ67284A:  UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 25JBF743;  Medline Kit Number/SKU DYNJ67284A:  UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 25IBA573;  Medline Kit Number/SKU DYNJ67284A:  UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24IBO985;  Medline Kit Number/SKU DYNJ67284A:  UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24IBB916;  Medline Kit Number/SKU DYNJ67284A:  UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24GBY148;  Medline Kit Number/SKU DYNJ67284A:  UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24EBO714;  Medline Kit Number/SKU DYNJ67284A:  UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 23LBH320;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23KBO017;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23JBA275;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23GBK387;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23CBD302;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 26ABF562;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 25GBF664;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 25EBB838;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 25BBQ021;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24LBB454;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24JBE139;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24GBI010;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24FBR965;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24DBQ797;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24BBH448;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23LBL498;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23KBX879;  Medline Kit Number/SKU DYNJ84478:  UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 23IBE948;  Medline Kit Number/SKU DYNJ84478:  UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 23FBB413;  Medline Kit Number/SKU DYNJ84478:  UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 24ABN367;  Medline Kit Number/SKU DYNJ84478:  UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 24ABA089;  Medline Kit Number/SKU DYNJ84478:  UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 23KBU302;  Medline Kit Number/SKU DYNJ85025:  UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 25LBL874;  Medline Kit Number/SKU DYNJ85025:  UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 25HBD880;  Medline Kit Number/SKU DYNJ85025:  UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 25EBI919;  Medline Kit Number/SKU DYNJ85025:  UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 24LBG184;  Medline Kit Number/SKU DYNJ85025:  UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 24LBF578;  Medline Kit Number/SKU DYNJ85025:  UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 24JBS764;  Medline Kit Number/SKU DYNJ89030:  UDI/DI each 10198459229725, UDI/DI case 40198459229726, Lot Number: 25JBH439;  Medline Kit Number/SKU DYNJ89030:  UDI/DI each 10198459229725, UDI/DI case 40198459229726, Lot Number: 25ABP922;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23IBW005;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23IBG214;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23FBP153;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23FBN621;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23EBW204;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23EBE141;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 24DBP594;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 24BBB058;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 24BBB100;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23LBE522;  Medline Kit Number/SKU DYNJ909065:  UDI/DI each 10195327260019, UDI/DI case 40195327260010, Lot Number: 23CMB048;  Medline Kit Number/SKU DYNJ909065:  UDI/DI each 10195327260019, UDI/DI case 40195327260010, Lot Number: 23CMA495;  Medline Kit Number/SKU DYNJ909065:  UDI/DI each 10195327260019, UDI/DI case 40195327260010, Lot Number: 22LMD749;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 23HMI877;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 23HMH413;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 25GMJ496;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 25DMD357;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 25AMJ130;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24IME711;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24HME507;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24DMF364;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24CMI687;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24CMG984;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24BMI425.\n\n## Distribution\nWorldwide distribution."}