Recall archive / FDA device enforcement
Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; 3) A... — FDA record Z-1436-2025
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 Feb 11, 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 procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; 3) ANGIO PACK-LF, Pack Number DYNJ0954970G; 4) ANGIOGRAPHY 6 FRENCH PACK, Pack Number DYNJ33597J; 5) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ38120B; 6) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ42873; 7) ANGIOGRAPHY PACK, Pack Number DYNJ57498; 8) ANGIOGRAPHY PACK, Pack Number DYNJ52167A; 9) ANGIOGRAPHY PACK, Pack Number DYNJV0173I; 10) ANGIOGRAPHY TRAY-LF, Pack Number DYNJ58722A; 11) CATH LAB PACK, Pack Number DYNJ42912F; 12) CATH LAB PK, Pack Number DYNJ35643B; 13) CATH PACK-LF, Pack Number DYNJ0367643Q; 14) CRMS ANGIO PACK-LF, Pack Number PHS616026002A; 15) DEPAUL ANGIO CATH PACK, Pack Number DYNJ24542L
- Reason
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1939 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1436-2025
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 | 1) Pack Number DYNJ50624A: UDI/DI 10889942474639 (each) 40889942474630 (case), Lot Number 20BDB393A; 2) Pack Number DYNJ30501F: UDI/DI 10889942806683 (each) 40889942806684 (case), Lot Number 21HBP134A; 3) Pack Number DYNJ0954970G: UDI/DI 10193489505634 (each) 40193489505635 (case), Lot Number 21GMA850A; 4) Pack Number DYNJ33597J: UDI/DI 10889942802012 (each) 40889942802013 (case), Lot Number 21IMD296A; 5) Pack Number DYNJ38120B: UDI/DI 10884389722145 (each) 40884389722146 (case), Lot Number 21BBI114A; 6) Pack Number DYNJ42873: UDI/DI 10888277011298 (each) 40888277011299 (case), Lot Number 23EBE560A; 7) Pack Number DYNJ57498: UDI/DI 10889942745746 (each) 40889942745747 (case), Lot Number 21AMA569A; 8) Pack Number DYNJ52167A: UDI/DI 10193489541106 (each) 40193489541107 (case), Lot Number 21GMB606A; 9) Pack Number DYNJV0173I: UDI/DI 10889942965021 (each) 40889942965022 (case), Lot Number 23CLA070A; 10) Pack Number DYNJ58722A: UDI/DI 10193489329698 (each) 40193489329699 (case), Lot Number 21IME955A; 11) Pack Number DYNJ42912F: UDI/DI 10193489785753 (each) 40193489785754 (case), Lot Number 23LBU921Z; 12) Pack Number DYNJ35643B: UDI/DI 10193489223712 (each) 40193489223713 (case), Lot Number 21BBG490A; 13) Pack Number DYNJ0367643Q: UDI/DI 10193489648614 (each) 40193489648615 (case), Lot Number 23EBE428A; 14) Pack Number PHS616026002A: UDI/DI 10889942429370 (each) 40889942429371 (case), Lot Number 23BBS889A; 15) Pack Number DYNJ24542L: UDI/DI 10193489651119 (each) 40193489651110 (case), Lot Number 20FBN798A |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
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
- Apr 2, 2025
- Recall initiation date
- Feb 11, 2025
- Center classification date
- Mar 25, 2025
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.