Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DY...

Published: April 29, 2026Recall ID: Z-1839-2026Category: devicesCountry: US

Reason for Recall / Hazard

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C

Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C

Field	Value
City	Northfield
State	IL
Event id	98599
Address 1	3 Lakes Dr
Address 2	N/A
Code info	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
Postal code	60093-2753
Report date	20260429
Product type	Devices
Product quantity	513 units
Reason for recall	The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Voluntary mandated	Voluntary: Firm initiated
Recall initiation date	20260225
Initial firm notification	Letter
Center classification date	20260417