Medline Industries, LP recalls Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- Lot #
- 25HBB410; Medline kit SKU DYKS1448B, UDI/DI 10195327691349 (EA) 40195327691340 (CS)
- Lot #
- 25HBE055; Medline kit SKU DYKS1163G, UDI/DI 10195327503185 (EA) 40195327503186 (CS)
- Lot #
- 25HBF057; Medline kit SKU DYKS1487I, UDI/DI 10198459415678 (EA) 40198459415679 (CS)
- Lot #
- 25HBI512; Medline kit SKU DYKS2056A, UDI/DI 10198459467493 (EA) 40198459467494 (CS)
- Lot #
- 25HBK906; Medline kit SKU DYKS2074, UDI/DI 10198459399893 (EA) 40198459399894 (CS)
- Lot #
- 25HBV987; Medline kit SKU DYKS2083, UDI/DI 10198459435126 (EA) 40198459435127 (CS)
- Lot #
- 25HLA076; Medline kit SKU DYKS1552B, UDI/DI 10198459269523 (EA) 40198459269524 (CS)
- Lot #
- 25HLA432; Medline kit SKU DYKS1362A, UDI/DI 10195327343163 (EA) 40195327343164 (CS)
- Lot #
- 25HLA829; Medline kit SKU DYKS1124C, UDI/DI 10198459447877 (EA) 40198459447878 (CS)
- Lot #
- 25HMB303; Medline kit SKU DYKS1313A, UDI/DI 10198459370595 (EA) 40198459370596 (CS)
- Lot #
- 25HMB948; Medline kit SKU DYKS1544F, UDI/DI 10198459411700 (EA) 40198459411701 (CS)
- Lot #
- 25HMC488; Medline kit SKU DYKS1507B, UDI/DI 10198459489372 (EA) 40198459489373 (CS)
- Lot #
- 25HMD440; Medline kit SKU DYKS1124C, UDI/DI 10198459447877 (EA) 40198459447878 (CS)
- Lot #
- 25HMF480; Medline kit SKU DYKS1130B, UDI/DI 10198459377129 (EA) 40198459377120 (CS)
- Lot #
- 25IBC508; Medline kit SKU DYKS1378B, UDI/DI 10195327521660 (EA) 40195327521661 (CS)
- Lot #
- 25IBI706; Medline kit SKU DYKS1551B, UDI/DI 10198459347702 (EA) 40198459347703 (CS)
- Lot #
- 25IBK720; Medline kit SKU DYKS1580, UDI/DI 10198459024320 (EA) 40198459024321 (CS)
- Lot #
- 25IBL590; Medline kit SKU DYKS2076, UDI/DI 10198459399732 (EA) 40198459399733 (CS)
- Lot #
- 25IBL885; Medline kit SKU DYKS1163G, UDI/DI 10195327503185 (EA) 40195327503186 (CS)
- Lot #
- 25IBQ969; Medline kit SKU DYKS1518A, UDI/DI 10198459032448 (EA) 40198459032449 (CS)
- Lot #
- 25IBU385; Medline kit SKU DYKS1489F, UDI/DI 10198459291272 (EA) 40198459291273 (CS)
- Lot #
- 25IBW167; Medline kit SKU DYKS1337D, UDI/DI 10198459078415 (EA) 40198459078416 (CS)
- Lot #
- 25ILA943; Medline kit SKU DYKS1468, UDI/DI 10195327411213 (EA) 40195327411214 (CS)
- Lot #
- 25ILA944; Medline kit SKU DYKS1467B, UDI/DI 10198459025648 (EA) 40198459025649 (CS)
- Lot #
- 25IME692; Medline kit SKU DYKS1379B, UDI/DI 10195327387433 (EA) 40195327387434 (CS)
- Lot #
- 25JBB244; Medline kit SKU DYKS1551B, UDI/DI 10198459347702 (EA) 40198459347703 (CS)
- Lot #
- 25JBC342; Medline kit SKU DYKS1551B, UDI/DI 10198459347702 (EA) 40198459347703 (CS)
- Lot #
- 25JBE269; Medline kit SKU DYKS2076, UDI/DI 10198459399732 (EA) 40198459399733 (CS)
- Lot #
- 25JBE865; Medline kit SKU DYKS1128C, UDI/DI 10195327549374 (EA) 40195327549375 (CS)
- Lot #
- 25JBG502; Medline kit SKU DYKS1487I, UDI/DI 10198459415678 (EA) 40198459415679 (CS)
- Lot #
- 25JBJ439; Medline kit SKU DYKS2076, UDI/DI 10198459399732 (EA) 40198459399733 (CS)
- Lot #
- 25JBJ451; Medline kit SKU DYKS1263G, UDI/DI 10198459557330 (EA) 40198459557331 (CS)
- Lot #
- 25JBL575; Medline kit SKU DYKS1448B, UDI/DI 10195327691349 (EA) 40195327691340 (CS)
- Lot #
- 25JBO961; Medline kit SKU DYKS1482A, UDI/DI 10198459011368 (EA) 40198459011369 (CS)
- Lot #
- 25JBR391; Medline kit SKU DYKS1382A, UDI/DI 10195327482602 (EA) 40195327482603 (CS)
- Lot #
- 25JBS091; Medline kit SKU DYKS1580, UDI/DI 10198459024320 (EA) 40198459024321 (CS)
- Lot #
- 25JBU194; Medline kit SKU DYKS1379B, UDI/DI 10195327387433 (EA) 40195327387434 (CS)
- Lot #
- 25JBU341; Medline kit SKU DYKS1325A, UDI/DI 10195327549343 (EA) 40195327549344 (CS)
- Lot #
- 25JBU577; Medline kit SKU DYKS1552B, UDI/DI 10198459269523 (EA) 40198459269524 (CS)
- Lot #
- 25JLA660; Medline kit SKU DYKS1458F, UDI/DI 10198459477942 (EA) 40198459477943 (CS)
- Lot #
- 25JLA986; Medline kit SKU DYKS1416F, UDI/DI 10198459508561 (EA) 40198459508562 (CS)
- Lot #
- 25JLB077; Medline kit SKU DYKS1124C, UDI/DI 10198459447877 (EA) 40198459447878 (CS)
- Lot #
- 25JMD403; Medline kit SKU DYKS1544F, UDI/DI 10198459411700 (EA) 40198459411701 (CS)
- Lot #
- 25JMD404; Medline kit SKU DYKS1093B, UDI/DI 10198459544545 (EA) 40198459544546 (CS)
- Lot #
- 25JMF248; Medline kit SKU DYKS1313A, UDI/DI 10198459370595 (EA) 40198459370596 (CS)
- Lot #
- 25JMH456; Medline kit SKU DYKS2103, UDI/DI 10198459550539 (EA) 40198459550530 (CS)
- Lot #
- 25JML466; Medline kit SKU DYKS2024A, UDI/DI 10198459547201 (EA) 40198459547202 (CS)
- Lot #
- 25KBC077; Medline kit SKU DYKS1128C, UDI/DI 10195327549374 (EA) 40195327549375 (CS)
- Lot #
- 25KBH159; Medline kit SKU DYKS1379B, UDI/DI 10195327387433 (EA) 40195327387434 (CS)
- Lot #
- 25KBL301; Medline kit SKU DYKS1362A, UDI/DI 10195327343163 (EA) 40195327343164 (CS)
- Lot #
- 25KLA016; Medline kit SKU DYKS1468, UDI/DI 10195327411213 (EA) 40195327411214 (CS)
- Lot #
- 25KLA028; Medline kit SKU DYKS1552B, UDI/DI 10198459269523 (EA) 40198459269524 (CS)
- Lot #
- 25KLA029; Medline kit SKU DYKS1337D, UDI/DI 10198459078415 (EA) 40198459078416 (CS)
- Lot #
- 25KLA107; Medline kit SKU DYKS1467B, UDI/DI 10198459025648 (EA) 40198459025649 (CS)
- Lot #
- 25KME034; Medline kit SKU DYKS2074A, UDI/DI 10198459528651 (EA) 40198459528652 (CS)
- Lot #
- 25KME090
Show 46 more code fieldsShow fewer
What the firm is doing
Medline issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 11/26/2025 via email and USPS first class mail. The notice explained the issue potential risk to the patient, and referred the consignee to the attached B Braun notice for further instructions. The B Braun notice provide "Interim Measures for Users" to provide for the continued use of the product. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
DistributionShow detailsHide
US Nationwide distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1057-2026
- FDA device classification · OJUOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4800The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems S…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems D…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Re…
Due to catheter separation
- Aortic Aneurysm Treatment Endovascular Graft System
- Under Investigation by firm
