{"url_path":"/fda/device/recalls/Z-2147-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline medical convenience kits, containing Namic Manifold, Labeled as:    1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508;   2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075;   3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N;   4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G;   5. CATH LAB PACK-LF, Medline Kit Number/SK…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-24","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2147-2026%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":1471,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2147-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-24\n**Report date:** 2026-05-20\n\n## Product\nMedline medical convenience kits, containing Namic Manifold, Labeled as:    1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508;   2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075;   3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N;   4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G;   5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D;   6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F;   7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G;   8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I;   9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C;   10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C;   11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D;   12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F;   13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911;   14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A;   15. CATH PACK, Medline Kit Number/SKU DYNJT6544;   16. LHK, Medline Kit Number/SKU NAM0015;   17. SLU LHK, Medline Kit Number/SKU SAMPC0706.\n\n## Reason\nMedline has identified the presence of particulate within the fluid path of the Manifolds.\n\n## Affected lots\nMedline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23KBN009;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23LBI829;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24ABH036;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24BBG055;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24EBO156;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24GBS605;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24IBK765;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25ABR102;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25CBK686;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25DBR341;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25EBB568;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25FBB624;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25GBC747;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25HBF702;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25JBJ140;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 26ABB718;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 26BBI625;  Medline Kit Number/SKU 60160075:  UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23IBC156;  Medline Kit Number/SKU 60160075:  UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23KBB857;  Medline Kit Number/SKU 60160075:  UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24ABL640;  Medline Kit Number/SKU 60160075:  UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24CBD613;  Medline Kit Number/SKU 60160075:  UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24EBQ349;  Medline Kit Number/SKU DYNJ04636N:  UDI/DI each 10198459580918, UDI/DI case 40198459580919, Lot Number: 26AMC406;  Medline Kit Number/SKU DYNJ04636N:  UDI/DI each 10198459580918, UDI/DI case 40198459580919, Lot Number: 26CMA066;  Medline Kit Number/SKU DYNJ24250G:  UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25GBI702;  Medline Kit Number/SKU DYNJ24250G:  UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25GBQ931;  Medline Kit Number/SKU DYNJ24250G:  UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25JBG417;  Medline Kit Number/SKU DYNJ24250G:  UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25KBH544;  Medline Kit Number/SKU DYNJ24250G:  UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26AMC371;  Medline Kit Number/SKU DYNJ24250G:  UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26AMC433;  Medline Kit Number/SKU DYNJ24250G:  UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26CMC609;  Medline Kit Number/SKU DYNJ24250G:  UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26CMC660;  Medline Kit Number/SKU DYNJ38333D:  UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24GMH056;  Medline Kit Number/SKU DYNJ38333D:  UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24HMB740;  Medline Kit Number/SKU DYNJ38333D:  UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24JME459;  Medline Kit Number/SKU DYNJ38333D:  UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24KMJ018;  Medline Kit Number/SKU DYNJ38333D:  UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 25AMG765;  Medline Kit Number/SKU DYNJ38333F:  UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25CME621;  Medline Kit Number/SKU DYNJ38333F:  UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25EMB706;  Medline Kit Number/SKU DYNJ38333F:  UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25EME362;  Medline Kit Number/SKU DYNJ38333F:  UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25HME818;  Medline Kit Number/SKU DYNJ38333F:  UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25KME742;  Medline Kit Number/SKU DYNJ38333F:  UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 26AME732;  Medline Kit Number/SKU DYNJ38333F:  UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 26BME198;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24EMG321;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24GMA788;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24HMA312;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24IMI472;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24KMC197;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 25BMC031;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 25BMF563;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 25CMI786;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 25DMH709;  Medline Kit Number/SKU DYNJ50779I:  UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25GMF741;  Medline Kit Number/SKU DYNJ50779I:  UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25HME177;  Medline Kit Number/SKU DYNJ50779I:  UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25IME495;  Medline Kit Number/SKU DYNJ50779I:  UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25KMB250;  Medline Kit Number/SKU DYNJ50779I:  UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25LMC853;  Medline Kit Number/SKU DYNJ50779I:  UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 26CMD408;  Medline Kit Number/SKU DYNJ56140C:  UDI/DI each 10198459477218, UDI/DI case 40198459477219, Lot Number: 25HBV231;  Medline Kit Number/SKU DYNJ56140C:  UDI/DI each 10198459477218, UDI/DI case 40198459477219, Lot Number: 26ABK843;  Medline Kit Number/SKU DYNJ56140C:  UDI/DI each 10198459477218, UDI/DI case 40198459477219, Lot Number: 26CBE251;  Medline Kit Number/SKU DYNJ62310C:  UDI/DI each 10198459104299, UDI/DI case 40198459104290, Lot Number: 24JMG837;  Medline Kit Number/SKU DYNJ62310C:  UDI/DI each 10198459104299, UDI/DI case 40198459104290, Lot Number: 24JMH356;  Medline Kit Number/SKU DYNJ62310C:  UDI/DI each 10198459104299, UDI/DI case 40198459104290, Lot Number: 24KMA339;  Medline Kit Number/SKU DYNJ62310C:  UDI/DI each 10198459104299, UDI/DI case 40198459104290, Lot Number: 24KMC940;  Medline Kit Number/SKU DYNJ62310D:  UDI/DI each 10198459254727, UDI/DI case 40198459254728, Lot Number: 25BMA421;  Medline Kit Number/SKU DYNJ62310D:  UDI/DI each 10198459254727, UDI/DI case 40198459254728, Lot Number: 25BME140;  Medline Kit Number/SKU DYNJ62310D:  UDI/DI each 10198459254727, UDI/DI case 40198459254728, Lot Number: 25CMH080;  Medline Kit Number/SKU DYNJ62310D:  UDI/DI each 10198459254727, UDI/DI case 40198459254728, Lot Number: 25DMB438;  Medline Kit Number/SKU DYNJ62310D:  UDI/DI each 10198459254727, UDI/DI case 40198459254728, Lot Number: 25EMA045;  Medline Kit Number/SKU DYNJ62310F:  UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 25GMI604;  Medline Kit Number/SKU DYNJ62310F:  UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 25HME419;  Medline Kit Number/SKU DYNJ62310F:  UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 25JMF984;  Medline Kit Number/SKU DYNJ62310F:  UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 25KMC303;  Medline Kit Number/SKU DYNJ62310F:  UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 25KMJ733;  Medline Kit Number/SKU DYNJ62310F:  UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 26BMD977;  Medline Kit Number/SKU DYNJ81911:  UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23HBE467;  Medline Kit Number/SKU DYNJ81911:  UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23HBW249;  Medline Kit Number/SKU DYNJ81911:  UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23HBW251;  Medline Kit Number/SKU DYNJ81911:  UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23IBC125;  Medline Kit Number/SKU DYNJ81911:  UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23KBJ681;  Medline Kit Number/SKU DYNJ81911:  UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23KBT543;  Medline Kit Number/SKU DYNJ81911:  UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23LBM984;  Medline Kit Number/SKU DYNJ81911:  UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 24BBR688;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 24EBP711;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 24GBP073;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 24IBF171;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 24KBH753;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 24LBH071;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 25ABM562;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 25CBM896;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 25FBJ466;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 25HBJ125;  Medline Kit Number/SKU DYNJT6544:  UDI/DI each 10198459558689, UDI/DI case 40198459558680, Lot Number: 25KMF858;  Medline Kit Number/SKU DYNJT6544:  UDI/DI each 10198459558689, UDI/DI case 40198459558680, Lot Number: 26BMK015;  Medline Kit Number/SKU NAM0015:  UDI/DI each 10195327374198, UDI/DI case 40195327374199, Lot Number: 23GBQ457;  Medline Kit Number/SKU SAMPC0706:  UDI/DI each 10195327586157, UDI/DI case 40195327586158, Lot Number: 24ADA538.\n\n## Distribution\nUS (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK."}