Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pac...
FDA Device Recall #Z-1436-2025 — Class II — February 11, 2025
Recall Summary
| Recall Number | Z-1436-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 11, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 1939 units |
Product Description
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 for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Lot / Code Information
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
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
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.