Recall archive / FDA device enforcement
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) IV START KIT NS,... — FDA record Z-1056-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 26, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Medline Industries, LP
- Quantity
- 5314 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1056-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 21, 2026
- Recall initiation date
- Nov 26, 2025
- Center classification date
- Jan 12, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.