FDA Device recall Z-1618-2025

Refer to RES

FDA Device
Class II
ongoing
Published 2025-04-23

On 2025-04-23 the FDA classified a Class II recall of Refer to RES by Medline Industries Northfield, citing there is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1618-2025
Classification	Class II
Status	ongoing
Initiated	2025-03-03
Published	2025-04-23
Last updated	2026-09-13 11:57 UTC
Company	Medline Industries Northfield
Distribution	US

Product

Refer to RES

Reason

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Identifiers

code_info	1) DYNJ61594, UDI-DI: 10193489586121(each), 40193489586122(case), Lot Number: 24IBF062; 2) DYNJ31798D, UDI-DI: 10195327… 1) DYNJ61594, UDI-DI: 10193489586121(each), 40193489586122(case), Lot Number: 24IBF062; 2) DYNJ31798D, UDI-DI: 10195327609078(each), 40195327609079(case), Lot Number: 24IBF219; 3) DYNJ46311F, UDI-DI: 10193489933185(each), 40193489933186(case), Lot Number: 24IBF751; 4) DYNJ49386A, UDI-DI: 10889942292882(each), 40889942292883(case), Lot Number: 24IBF768; 5) DYNJ51781G, UDI-DI: 10198459045974(each), 40198459045975(case), Lot Number: 24IBG614; 6) DYNJ54474C, UDI-DI: 10195327698560(each), 40195327698561(case), Lot Number: 24IBG988; 7) DYNJ46311F, UDI-DI: 10193489933185(each), 40193489933186(case), Lot Number: 24IBH023; 8) DYNJ65348, UDI-DI: 10193489268881(each), 40193489268882(case), Lot Number: 24IBH081; 9) DYNJ37322I, UDI-DI: 10193489961553(each), 40193489961554(case), Lot Number: 24IBH579; 10) DYNJ69926A, UDI-DI: 10195327153601(each), 40195327153602(case), Lot Number: 24IBH589; 11) DYNJ39903, UDI-DI: 10884389842072(each), 40884389842073(case), Lot Number: 24IBH647; 12) DYNJ47816B, UDI-DI

code_info

1) DYNJ61594, UDI-DI: 10193489586121(each), 40193489586122(case), Lot Number: 24IBF062; 2) DYNJ31798D, UDI-DI: 10195327…

1) DYNJ61594, UDI-DI: 10193489586121(each), 40193489586122(case), Lot Number: 24IBF062; 2) DYNJ31798D, UDI-DI: 10195327609078(each), 40195327609079(case), Lot Number: 24IBF219; 3) DYNJ46311F, UDI-DI: 10193489933185(each), 40193489933186(case), Lot Number: 24IBF751; 4) DYNJ49386A, UDI-DI: 10889942292882(each), 40889942292883(case), Lot Number: 24IBF768; 5) DYNJ51781G, UDI-DI: 10198459045974(each), 40198459045975(case), Lot Number: 24IBG614; 6) DYNJ54474C, UDI-DI: 10195327698560(each), 40195327698561(case), Lot Number: 24IBG988; 7) DYNJ46311F, UDI-DI: 10193489933185(each), 40193489933186(case), Lot Number: 24IBH023; 8) DYNJ65348, UDI-DI: 10193489268881(each), 40193489268882(case), Lot Number: 24IBH081; 9) DYNJ37322I, UDI-DI: 10193489961553(each), 40193489961554(case), Lot Number: 24IBH579; 10) DYNJ69926A, UDI-DI: 10195327153601(each), 40195327153602(case), Lot Number: 24IBH589; 11) DYNJ39903, UDI-DI: 10884389842072(each), 40884389842073(case), Lot Number: 24IBH647; 12) DYNJ47816B, UDI-DI

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1618-2025%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.