Recall Z-1056-2026
Medline Industries, LP · initiated November 26, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) IV START KIT NS, Medline kit SKU DYKM1980C; 2) (134) L&D IV-START SET, Medline kit SKU DYKM2137B; 3) IV START KIT, Medline kit SKU DYKS1372C; 4) IV START KIT, Medline kit SKU DYNDV1691B; 5) OUTPATIENT 2 TO 5 YEARS, Medline kit SKU DYNDV2464A.
Codes / lots: Medline kit SKU DYKM1980C, UDI/DI 10195327608309 (EA) 40195327608300 (CS), Lot Number 25JBB147; Medline kit SKU DYKM1980C, UDI/DI 10195327608309 (EA) 40195327608300 (CS), Lot Number 25KBL305; Medline kit SKU DYKM2137B, UDI/DI 10198459285615 (EA) 40198459285616 (CS), Lot Number 25HBT834; Medline kit SKU DYKM2137B, UDI/DI 10198459285615 (EA) 40198459285616 (CS), Lot Number 25IBJ757; Medline kit SKU DYKM2137B, UDI/DI 10198459285615 (EA) 40198459285616 (CS), Lot Number 25JBJ557; Medline kit SKU DYKS1372C, UDI/DI 10195327373504 (EA) 40195327373505 (CS), Lot Number 25JLA480; Medline kit SKU DYNDV1691B, UDI/DI 10195327658472 (EA) 40195327658473 (CS), Lot Number 25HBI335; Medline kit SKU DYNDV1691B, UDI/DI 10195327658472 (EA) 40195327658473 (CS), Lot Number 25IBE523; Medline kit SKU DYNDV1691B, UDI/DI 10195327658472 (EA) 40195327658473 (CS), Lot Number 25JBM702; Medline kit SKU DYNDV2464A, UDI/DI 10195327065911 (EA) 40195327065912 (CS), Lot Number 25IBV942.
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1056-2026
- Initiated
- November 26, 2025
- Posted by FDA
- January 12, 2026
- Product code
- LRS – I.V. Start Kit
- Quantity
- 5314 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1049-2026 Class II | Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets…Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to… | 11/26/2025Open, Classified |
| Z-1050-2026 Class II | Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets…Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to… | 11/26/2025Open, Classified |
| Z-1051-2026 Class II | Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets…Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to… | 11/26/2025Open, Classified |
| Z-1052-2026 Class II | Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets…Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to… | 11/26/2025Open, Classified |
| Z-1053-2026 Class II | Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets…Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to… | 11/26/2025Open, Classified |
| Z-1054-2026 Class II | Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets…Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to… | 11/26/2025Open, Classified |
| Z-1055-2026 Class II | Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets…Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to… | 11/26/2025Open, Classified |
| Z-1057-2026 Class II | Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets…Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to… | 11/26/2025Open, Classified |
| Z-1058-2026 Class II | Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets…Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to… | 11/26/2025Open, Classified |
| Z-1059-2026 Class II | Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets…Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to… | 11/26/2025Open, Classified |
| Z-1060-2026 Class II | Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets…Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to… | 11/26/2025Open, Classified |