| | Class 2 Device Recall Medline Industries IV Administration and Extension Set |  |
| Date Initiated by Firm | December 31, 2025 |
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| Date Posted | February 13, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1366-2026 |
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| Recall Event ID |
98299 |
| 510(K)Number | K242126 |
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| Product Classification |
Set, administration, intravascular - Product Code FPA
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| Product | Medline Industries IV Administration and Extension Sets:
1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529;
2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029;
3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516;
4) DBD-IV ADMIN SET, 15DRP, 1 INJECT PORT,, Model Number: DYNDTB1530;
5) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 6, Model Number: DYNDTB1539;
6) DBD-IV ADMIN SET, 15DRP, 3 NF, 109, Model Number: DYNDTB1545;
7) IV ADMIN SET, 20DRP, 3 NF, 109, Model Number: DYNDTB2045;
8) DBD-IVADMINSET60DRP2NEEDLE-FREEVLVE96, Model Number: DYNDTB0512;
9) DBD-IVADMINSET,60DRP3 NEEDLE-FREE VLVE11, Model Number: DYNDTB0555;
10) IV ADMIN SET, 10DRP, NF,INJ, 96, Model Number: DYNDTB1022;
11) DBD-IV ADMIN SET, 15DRP, 2NF, 96, Model Number: DYNDTB1512;
12) DBD-IV ADMIN SET, 15DRP, 1NF, 92, Model Number: DYNDTB1529;
13) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 9, Model Number: DYNDTB1537;
14) DBD-IV ADMIN SET, 15DRP, SECOND, 40, Model Number: DYNDTB1540;
15) IV ADMIN SET, 20DRP, 1NF, 92, Model Number: DYNDTB2029;
16) DBD-IV EXT SET, 6.5, 1.1ML, M LUERLOCK,, Model Number: DYNDTB5077;
17) IV ADMIN SET, 10DRP, 3 NF, 109, Model Number: DYNDTB1045;
18) DBD-IVADMISET15DRP4NEEDLEFREE VLVESTPCK1, Model Number: DYNDTB1545D;
19) IV ADMIN SET15DRPFLWCTRL1NEEDLEFREE VA, Model Number: DYNDTB2524;
20) IV ADMIN SET, 10DRP, 2NF, 96, Model Number: DYNDTB1012;
21) IV ADMIN SET, 20DRP, 2NF, 96, Model Number: DYNDTB2012;
22) IV ADMIN SET, 20DRP, NF,INJ, 96, Model Number: DYNDTB2022;
23) DBD-IV EXT SET,SMBORE EXT,8,M LUERLOCK,1, Model Number: DYNDTB5081 |
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| Code Information |
1) DYNDTB0529, UDI-DI: 10197344105663(each), 20197344105660(case), Lot Number: All Lot Numbers;
2) DYNDTB1029, UDI-DI: 10197344076956(each), 20197344076953(case), Lot Number: All Lot Numbers;
3) DYNDTB1516, UDI-DI: 10197344105687(each), 20197344105684(case), Lot Number: All Lot Numbers;
4) DYNDTB1530, UDI-DI: 10197344105694(each), 20197344105691(case), Lot Number: All Lot Numbers;
5) DYNDTB1539, UDI-DI: 10197344008254(each), 20197344008251(case), Lot Number: All Lot Numbers;
6) DYNDTB1545, UDI-DI: 10197344098644(each), 20197344098641(case), Lot Number: All Lot Numbers;
7) DYNDTB2045, UDI-DI: 10197344077007(each), 20197344077004(case), Lot Number: All Lot Numbers;
8) DYNDTB0512, UDI-DI: 10197344105656(each), 20197344105653(case), Lot Number: All Lot Numbers;
9) DYNDTB0555, UDI-DI: 10197344105670(each), 20197344105677(case), Lot Number: All Lot Numbers;
10) DYNDTB1022, UDI-DI: 10197344076949(each), 20197344076946(case), Lot Number: All Lot Numbers;
11) DYNDTB1512, UDI-DI: 10197344098613(each), 20197344098610(case), Lot Number: All Lot Numbers;
12) DYNDTB1529, UDI-DI: 10197344098620(each), 20197344098627(case), Lot Number: All Lot Numbers;
13) DYNDTB1537, UDI-DI: 10197344008247(each), 20197344008244(case), Lot Number: All Lot Numbers;
14) DYNDTB1540, UDI-DI: 10197344098637(each), 20197344098634(case), Lot Number: All Lot Numbers;
15) DYNDTB2029, UDI-DI: 10197344076994(each), 20197344076991(case), Lot Number: All Lot Numbers;
16) DYNDTB5077, UDI-DI: 10197344098651(each), 20197344098658(case), Lot Number: All Lot Numbers;
17) DYNDTB1045, UDI-DI: 10197344076963(each), 20197344076960(case), Lot Number: All Lot Numbers;
18) DYNDTB1545D, UDI-DI: 10197344105700(each), 20197344105707(case), Lot Number: All Lot Numbers;
19) DYNDTB2524, UDI-DI: 10197344105717(each), 20197344105714(case), Lot Number: All Lot Numbers;
20) DYNDTB1012, UDI-DI: 10197344076932(each), 20197344076939(case), Lot Number: All Lot Numbers;
21) DYNDTB2012, UDI-DI: 10197344076970(each), 20197344076977(case), Lot Number: All Lot Numbers;
22) DYNDTB2022, UDI-DI: 10197344076987(each), 20197344076984(case), Lot Number: All Lot Numbers;
23) DYNDTB5081, UDI-DI: 10197344098668(each), 20197344098665(case), Lot Number: All Lot Numbers |
| FEI Number |
1417592
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Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Haley Barclay
866-359-1704 |
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Manufacturer Reason
for Recall | Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication. |
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FDA Determined
Cause 2 | Process control |
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| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 12/31/25 was sent to customers.
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-25-262
Recall Code:
3. Your account will receive credit once the response form is submitted.
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 request that customers destroy any affected product. You should include your customers quantities on your response form.
If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
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| Quantity in Commerce | 926,227 units |
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| Distribution | Worldwide distribution - US Nationwide and the country of Bahamas. |
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| Total Product Life Cycle | TPLC Device Report |
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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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| 510(K) Database | 510(K)s with Product Code = FPA
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