Z-1839-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2026
- Initiation Date
- February 25, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 513 units
Product Description
Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C
Reason for Recall
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Distribution Pattern
US Nationwide distribution.
Code Information
1) DYNJ59030B, UDI-DI: 10198459176920(each), 40198459176921(case), Lot Number: 24KBL574; 2) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 24IBJ666; 3) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 24JBM014; 4) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 24KBE220; 5) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 24LBJ174; 6) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 25ABW145; 7) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 25CBK525; 8) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 25EBA897; 9) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 25GBK561; 10) VASC1081C, UDI-DI: 10195327054519(each), 40195327054510(case), Lot Number: 25FBA927