| | Class 1 Device Recall Medline medical convenience kits |  |
| Date Initiated by Firm | March 24, 2026 |
| Date Posted | May 08, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2147-2026 |
| Recall Event ID |
98735 |
| Product Classification |
General surgery tray - Product Code LRO
|
| Product | 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. |
| 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. |
| FEI Number |
1417592
|
Recalling Firm/ Manufacturer |
Medline Industries, LP 3 Lakes Dr Northfield IL 60093-2753
|
| For Additional Information Contact | Haley Barclay 866-359-1704 |
Manufacturer Reason for Recall | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
FDA Determined Cause 2 | Under Investigation by firm |
| Action | Medline Industries, LP issued an URGENT MEDICAL DEVICE notice to its consignees on 3/24/2026 via email and mail. The notice explained the issue, potential risk and requested the following:
"REQUIRED ACTION:
1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product.
2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form.
Website link: https://recalls.medline.com
Recall Reference #: R-26-046
Recall Code:
3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.
4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product."
For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
| Quantity in Commerce | 21119 kits |
| Distribution | US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
|
| Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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