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

FDA Device Recall #Z-1057-2026 — Class II — November 26, 2025

Recall Summary

Recall Number Z-1057-2026
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 11173 units

Product Description

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.

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 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.

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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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