Class II FDA device recall · Z-1057-2026

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) PRE OP KIT, Medline kit SKU DYKS1124C; 3) PRE OP KIT, Medline kit SKU DYKS1128C; 4) PREOP KIT, Medline kit SKU DYKS1130B; 5) PRE OP KIT, Medline kit SKU DYKS1163G; 6) PRE OP KIT SURGERY, Medline kit SKU DYKS1263G; 7) PREOP KIT, Medline kit SKU DYKS1313A; 8) PRE OP KIT, Medline kit SKU DYKS1325A; 9) ADULT PRE OP KIT, Medline kit SKU DYKS1337D; 10) PRE OP KIT ADULT, Medline kit SKU DYKS1362A; 11) PRE-OP - OUTPATIENT KIT, Medline kit SKU DYKS1378B; 12) PRE-OP INPATIENT KIT, Medline kit SKU DYKS1379B; 13) PRE OP KIT, Medline kit SKU DYKS1382A; 14) PRE OP KIT, Medline kit SKU DYKS1416F; 15) PREOP KIT, Medline kit SKU DYKS1448B; 16) PRE-OP KIT, Medline kit SKU DYKS1458F; 17) PRE OP KIT, Medline kit SKU DYKS1467B; 18) PRE OP KIT, Medline kit SKU DYKS1468; 19) PRE-OP, Medline kit SKU DYKS1482A; 20) ADULT PRE OP, Medline kit SKU DYKS1487I; 21) PRE OP ENDO, Medline kit SKU DYKS1489F; 22) PREOP KIT, Medline kit SKU DYKS1507B; 23) PRE OP KIT, Medline kit SKU DYKS1518A; 24) PRE OP KIT, Medline kit SKU DYKS1544F; 25) PREOP, Medline kit SKU DYKS1551B; 26) PREOP, Medline kit SKU DYKS1552B; 27) PREOP, Medline kit SKU DYKS1580; 28) PRE OP KIT, Medline kit SKU DYKS2024A; 29) PRE OP KIT, Medline kit SKU DYKS2056A; 30) PRE-OP KIT, Medline kit SKU DYKS2074; 31) PRE-OP KIT, Medline kit SKU DYKS2074A; 32) PREOP KIT, Medline kit SKU DYKS2076; 33) PRE OP KIT 1, Medline kit SKU DYKS2083; 34) PRE OP KIT, Medline kit SKU DYKS2103.

Why it was recalled

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

Medline kit SKU DYKS1378B, UDI/DI 10195327521660 (EA) 40195327521661 (CS), Lot Number 25HBB410;  Medline kit SKU DYKS1448B, UDI/DI 10195327691349 (EA) 40195327691340 (CS), Lot Number 25HBE055;  Medline kit SKU DYKS1163G, UDI/DI 10195327503185 (EA) 40195327503186 (CS), Lot Number 25HBF057;  Medline kit SKU DYKS1487I, UDI/DI 10198459415678 (EA) 40198459415679 (CS), Lot Number 25HBI512;  Medline kit SKU DYKS2056A, UDI/DI 10198459467493 (EA) 40198459467494 (CS), Lot Number 25HBK906;  Medline kit SKU DYKS2074, UDI/DI 10198459399893 (EA) 40198459399894 (CS), Lot Number 25HBV987;  Medline kit SKU DYKS2083, UDI/DI 10198459435126 (EA) 40198459435127 (CS), Lot Number 25HLA076;  Medline kit SKU DYKS1552B, UDI/DI 10198459269523 (EA) 40198459269524 (CS), Lot Number 25HLA432;  Medline kit SKU DYKS1362A, UDI/DI 10195327343163 (EA) 40195327343164 (CS), Lot Number 25HLA829;  Medline kit SKU DYKS1124C, UDI/DI 10198459447877 (EA) 40198459447878 (CS), Lot Number 25HMB303;  Medline kit SKU DYKS1313A, UDI/DI 10198459370595 (EA) 40198459370596 (CS), Lot Number 25HMB948;  Medline kit SKU DYKS1544F, UDI/DI 10198459411700 (EA) 40198459411701 (CS), Lot Number 25HMC488;  Medline kit SKU DYKS1507B, UDI/DI 10198459489372 (EA) 40198459489373 (CS), Lot Number 25HMD440;  Medline kit SKU DYKS1124C, UDI/DI 10198459447877 (EA) 40198459447878 (CS), Lot Number 25HMF480;  Medline kit SKU DYKS1130B, UDI/DI 10198459377129 (EA) 40198459377120 (CS), Lot Number 25IBC508;  Medline kit SKU DYKS1378B, UDI/DI 10195327521660 (EA) 40195327521661 (CS), Lot Number 25IBI706;  Medline kit SKU DYKS1551B, UDI/DI 10198459347702 (EA) 40198459347703 (CS), Lot Number 25IBK720;  Medline kit SKU DYKS1580, UDI/DI 10198459024320 (EA) 40198459024321 (CS), Lot Number 25IBL590;  Medline kit SKU DYKS2076, UDI/DI 10198459399732 (EA) 40198459399733 (CS), Lot Number 25IBL885;  Medline kit SKU DYKS1163G, UDI/DI 10195327503185 (EA) 40195327503186 (CS), Lot Number 25IBQ969;  Medline kit SKU DYKS1518A, UDI/DI 10198459032448 (EA) 40198459032449 (CS), Lot Number 25IBU385;  Medline kit SKU DYKS1489F, UDI/DI 10198459291272 (EA) 40198459291273 (CS), Lot Number 25IBW167;  Medline kit SKU DYKS1337D, UDI/DI 10198459078415 (EA) 40198459078416 (CS), Lot Number 25ILA943;  Medline kit SKU DYKS1468, UDI/DI 10195327411213 (EA) 40195327411214 (CS), Lot Number 25ILA944;  Medline kit SKU DYKS1467B, UDI/DI 10198459025648 (EA) 40198459025649 (CS), Lot Number 25IME692;  Medline kit SKU DYKS1379B, UDI/DI 10195327387433 (EA) 40195327387434 (CS), Lot Number 25JBB244;  Medline kit SKU DYKS1551B, UDI/DI 10198459347702 (EA) 40198459347703 (CS), Lot Number 25JBC342;  Medline kit SKU DYKS1551B, UDI/DI 10198459347702 (EA) 40198459347703 (CS), Lot Number 25JBE269;  Medline kit SKU DYKS2076, UDI/DI 10198459399732 (EA) 40198459399733 (CS), Lot Number 25JBE865;  Medline kit SKU DYKS1128C, UDI/DI 10195327549374 (EA) 40195327549375 (CS), Lot Number 25JBG502;  Medline kit SKU DYKS1487I, UDI/DI 10198459415678 (EA) 40198459415679 (CS), Lot Number 25JBJ439;  Medline kit SKU DYKS2076, UDI/DI 10198459399732 (EA) 40198459399733 (CS), Lot Number 25JBJ451;  Medline kit SKU DYKS1263G, UDI/DI 10198459557330 (EA) 40198459557331 (CS), Lot Number 25JBL575;  Medline kit SKU DYKS1448B, UDI/DI 10195327691349 (EA) 40195327691340 (CS), Lot Number 25JBO961;  Medline kit SKU DYKS1482A, UDI/DI 10198459011368 (EA) 40198459011369 (CS), Lot Number 25JBR391;  Medline kit SKU DYKS1382A, UDI/DI 10195327482602 (EA) 40195327482603 (CS), Lot Number 25JBS091;  Medline kit SKU DYKS1580, UDI/DI 10198459024320 (EA) 40198459024321 (CS), Lot Number 25JBU194;  Medline kit SKU DYKS1379B, UDI/DI 10195327387433 (EA) 40195327387434 (CS), Lot Number 25JBU341;  Medline kit SKU DYKS1325A, UDI/DI 10195327549343 (EA) 40195327549344 (CS), Lot Number 25JBU577;  Medline kit SKU DYKS1552B, UDI/DI 10198459269523 (EA) 40198459269524 (CS), Lot Number 25JLA660;  Medline kit SKU DYKS1458F, UDI/DI 10198459477942 (EA) 40198459477943 (CS), Lot Number 25JLA986;  Medline kit SKU DYKS1416F, UDI/DI 10198459508561 (EA) 40198459508562 (CS), Lot Number 25JLB077;  Medline kit SKU DYKS1124C, UDI/DI 10198459447877 (EA) 40198459447878 (CS), Lot Number 25JMD403;  Medline kit SKU DYKS1544F, UDI/DI 10198459411700 (EA) 40198459411701 (CS), Lot Number 25JMD404;  Medline kit SKU DYKS1093B, UDI/DI 10198459544545 (EA) 40198459544546 (CS), Lot Number 25JMF248;  Medline kit SKU DYKS1313A, UDI/DI 10198459370595 (EA) 40198459370596 (CS), Lot Number 25JMH456;  Medline kit SKU DYKS2103, UDI/DI 10198459550539 (EA) 40198459550530 (CS), Lot Number 25JML466;  Medline kit SKU DYKS2024A, UDI/DI 10198459547201 (EA) 40198459547202 (CS), Lot Number 25KBC077;  Medline kit SKU DYKS1128C, UDI/DI 10195327549374 (EA) 40195327549375 (CS), Lot Number 25KBH159;  Medline kit SKU DYKS1379B, UDI/DI 10195327387433 (EA) 40195327387434 (CS), Lot Number 25KBL301;  Medline kit SKU DYKS1362A, UDI/DI 10195327343163 (EA) 40195327343164 (CS), Lot Number 25KLA016;  Medline kit SKU DYKS1468, UDI/DI 10195327411213 (EA) 40195327411214 (CS), Lot Number 25KLA028;  Medline kit SKU DYKS1552B, UDI/DI 10198459269523 (EA) 40198459269524 (CS), Lot Number 25KLA029;  Medline kit SKU DYKS1337D, UDI/DI 10198459078415 (EA) 40198459078416 (CS), Lot Number 25KLA107;  Medline kit SKU DYKS1467B, UDI/DI 10198459025648 (EA) 40198459025649 (CS), Lot Number 25KME034;  Medline kit SKU DYKS2074A, UDI/DI 10198459528651 (EA) 40198459528652 (CS), Lot Number 25KME090.

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

US Nationwide distribution.

Recall record

Recalling firm: Medline Industries, LP
Product type: Devices
Recall number: Z-1057-2026
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Northfield, IL
Recall initiated: 2025-11-26

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1057-2026 · Source: openFDA enforcement.