FDA Device recall Z-1839-2026

Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B

FDA Device
Class II
ongoing
Published 2026-04-29

On 2026-04-29 the FDA classified a Class II recall of Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B by Medline Industries, citing the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1839-2026
Classification	Class II
Status	ongoing
Initiated	2026-02-25
Published	2026-04-29
Last updated	2026-09-13 11:58 UTC
Company	Medline Industries
Distribution	US

Product

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

Reason

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Identifiers

code_info	1) DYNJ59030B, UDI-DI: 10198459176920(each), 40198459176921(case), Lot Number: 24KBL574; 2) DYNJ908586C, UDI-DI: 101984… 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

code_info

1) DYNJ59030B, UDI-DI: 10198459176920(each), 40198459176921(case), Lot Number: 24KBL574; 2) DYNJ908586C, UDI-DI: 101984…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1839-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.