Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Nu
Summary
The FDA issued a Class I for Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. M by Medline Industries, LP. Reason: Medline has identified the presence of particulate within the fluid path of the Manifolds..
Details
Source
Device Recall
External ID
Z-2147-2026
Action Date
2026-05-20
Status
Ongoing
Category
device
Product Description
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/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.
Lot/Code Info: Medline 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.
Quantity Affected: 21119 kits
Reason for Recall
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Distribution
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-24
Company
Northfield, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 243 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2147-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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