Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,...
FDA Device Recall #Z-2147-2026 - Class I, March 24, 2026
Recall Summary
| Recall Number | Z-2147-2026 |
| Classification | Class I - Serious risk |
| Date Initiated | March 24, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 21119 kits |
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.
Reason for Recall
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Distribution Pattern
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Lot / Code Information
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.
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2790-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2788-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2791-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2789-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2737-2026 | Class II | Medline Kits containing Zimmer Biomet mixing bo... | Jun 10, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.