Class II FDA device recall · Z-1055-2026

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) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C; 4) TOP DRAWER #6, Medline kit SKU ACC010688; 5) RRMC CODE CART DRAWER 3, Medline kit SKU ACC010770; 6) SURGERY BAG, Medline kit SKU DYKM1279C; 7) ADMISSION KIT, Medline kit SKU DYKS1179; 8) PRE OP KIT, Medline kit SKU DYKS1192C; 9) MEDLINE PEDIATRIC PATIENT PACK, Medline kit SKU DYKS1199B; 10) MEDLINE ADULT PATIENT PACKAGE, Medline kit SKU DYKS1200B; 11) GERMANTOWN PRE OP KIT, Medline kit SKU DYKS1248; 12) GERMANTOWN PRE OP BLOCK KIT, Medline kit SKU DYKS1249; 13) PRE OP KIT, Medline kit SKU DYKS1274A; 14) CATH LAB PRE OP START KIT, Medline kit SKU DYKS1324; 15) PRE OP KIT, Medline kit SKU DYKS1376; 16) PTC KIT, Medline kit SKU DYNDH1161A; 17) DR BROWN BODY, Medline kit SKU DYNJ910487.

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 ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25IDB125;  Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25IDB400;  Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25JDB835;  Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25KDA036;  Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25KDA248;  Medline kit SKU ACC010416B, UDI/DI 10195327223670 (EA) 40195327223671 (CS), Lot number 25IDA545;  Medline kit SKU ACC010416B, UDI/DI 10195327223670 (EA) 40195327223671 (CS), Lot number 25JDB867;  Medline kit SKU ACC010525C, UDI/DI 10198459027765 (EA) 40198459027766 (CS), Lot number 25KDA768;  Medline kit SKU ACC010688, UDI/DI 10195327432713 (EA) 40195327432714 (CS), Lot number 25HDB656;  Medline kit SKU ACC010688, UDI/DI 10195327432713 (EA) 40195327432714 (CS), Lot number 25IDA638;  Medline kit SKU ACC010688, UDI/DI 10195327432713 (EA) 40195327432714 (CS), Lot number 25JDA666;  Medline kit SKU ACC010770, UDI/DI 10195327576998 (EA) 40195327576999 (CS), Lot number 25HDA878;  Medline kit SKU ACC010770, UDI/DI 10195327576998 (EA) 40195327576999 (CS), Lot number 25IDA087;  Medline kit SKU ACC010770, UDI/DI 10195327576998 (EA) 40195327576999 (CS), Lot number 25IDA817;  Medline kit SKU ACC010770, UDI/DI 10195327576998 (EA) 40195327576999 (CS), Lot number 25JDB317;  Medline kit SKU DYKM1279C, UDI/DI 10889942519583 (EA) 40889942519584 (CS), Lot number 25IBL412;  Medline kit SKU DYKM1279C, UDI/DI 10889942519583 (EA) 40889942519584 (CS), Lot number 25KBK165;  Medline kit SKU DYKS1179, UDI/DI 10193489711981 (EA) 40193489711982 (CS), Lot number 25IMD671;  Medline kit SKU DYKS1179, UDI/DI 10193489711981 (EA) 40193489711982 (CS), Lot number 25JMG868;  Medline kit SKU DYKS1192C, UDI/DI 10193489849707 (EA) 40193489849708 (CS), Lot number 25KME757;  Medline kit SKU DYKS1199B, UDI/DI 10193489403831 (EA) 40193489403832 (CS), Lot number 25HBF059;  Medline kit SKU DYKS1199B, UDI/DI 10193489403831 (EA) 40193489403832 (CS), Lot number 25JBU391;  Medline kit SKU DYKS1200B, UDI/DI 10193489235425 (EA) 40193489235426 (CS), Lot number 25IBT744;  Medline kit SKU DYKS1200B, UDI/DI 10193489235425 (EA) 40193489235426 (CS), Lot number 25KBG976;  Medline kit SKU DYKS1248, UDI/DI 10193489305708 (EA) 40193489305709 (CS), Lot number 25JBS281;  Medline kit SKU DYKS1249, UDI/DI 10193489305715 (EA) 40193489305716 (CS), Lot number 25HBJ008;  Medline kit SKU DYKS1249, UDI/DI 10193489305715 (EA) 40193489305716 (CS), Lot number 25HBV936;  Medline kit SKU DYKS1249, UDI/DI 10193489305715 (EA) 40193489305716 (CS), Lot number 25IBB540;  Medline kit SKU DYKS1274A, UDI/DI 10195327058890 (EA) 40195327058891 (CS), Lot number 25HBF086;  Medline kit SKU DYKS1274A, UDI/DI 10195327058890 (EA) 40195327058891 (CS), Lot number 25IBF923;  Medline kit SKU DYKS1324, UDI/DI 10193489969962 (EA) 40193489969963 (CS), Lot number 25IBR790;  Medline kit SKU DYKS1376, UDI/DI 10195327216498 (EA) 40195327216499 (CS), Lot number 25HBF087;  Medline kit SKU DYKS1376, UDI/DI 10195327216498 (EA) 40195327216499 (CS), Lot number 25IBS865;  Medline kit SKU DYNDH1161A, UDI/DI 10889942731299 (EA) 40889942731290 (CS), Lot number 25HBG750;  Medline kit SKU DYNJ910487, UDI/DI 10198459004841 (EA) 40198459004842 (CS), Lot number 25GMK728;  Medline kit SKU DYNJ910487, UDI/DI 10198459004841 (EA) 40198459004842 (CS), Lot number 25HMI417;

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-1055-2026
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-1055-2026 · Source: openFDA enforcement.