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Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:...

FDA Device Recall #Z-1055-2026 — Class II — November 26, 2025

Recall Summary

Recall Number Z-1055-2026
Classification Class II — Moderate risk
Date Initiated November 26, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medline Industries, LP
Location Northfield, IL
Product Type Devices
Quantity 3045 units

Product Description

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.

Reason for Recall

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.

Distribution Pattern

US Nationwide distribution.

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;

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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.

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