FDA Device recall Z-1614-2025

Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A

FDA Device
Class II
ongoing
Published 2025-04-23

On 2025-04-23 the FDA classified a Class II recall of Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A 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-1614-2025
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

Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTION PCH-LF, Model Number: DYNJ81281; 3) C-SECTION PACK-LF, Model Number: OBK387M; 4) C-SECTION PCH-LF, Model Number: DYNJ81281; 5) NHS - C-SECTION SCG, Model Number: DYNJ40573A; 6) C-SECTION CDS, Model Number: CDS983998C; 7) C-SECTION ADD ON PACK, Model Number: DYNJ64300A; 8) EMERGENCY BIRTH PACK, Model Number: DYNJ55205; 9) C-SECTION PACK, Model Number: DYNJ56550; 10) C-SECTION ADD ON PACK, Model Number: DYNJ83507; 11) C-SECTION CLOSURE PACK, Model Number: DYNJ83248; 12) C-SECTION PCH-LF, Model Number: DYNJ81281

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) MNS13635A, UDI-DI: 10653160994244(each), 40653160994245(case), Lot Number: 24IBH747; 2) DYNJ81281, UDI-DI: 101953271… 1) MNS13635A, UDI-DI: 10653160994244(each), 40653160994245(case), Lot Number: 24IBH747; 2) DYNJ81281, UDI-DI: 10195327103620(each), 40195327103621(case), Lot Number: 24JBM309; 3) OBK387M, UDI-DI: 10889942686810(each), 40889942686811(case), Lot Number: 24JBM385; 4) DYNJ81281, UDI-DI: 10195327103620(each), 40195327103621(case), Lot Number: 24JBM576; 5) DYNJ40573A, UDI-DI: 10888277988514(each), 40888277988515(case), Lot Number: 24JBM871; 6) CDS983998C, UDI-DI: 10193489776713(each), 40193489776714(case), Lot Number: 24JBS915; 7) DYNJ64300A, UDI-DI: 10193489852370(each), 40193489852371(case), Lot Number: 24JBU461; 8) DYNJ55205, UDI-DI: 10889942532803(each), 40889942532804(case), Lot Number: 24JBV449; 9) DYNJ56550, UDI-DI: 10889942671779(each), 40889942671770(case), Lot Number: 24JBV561; 10) DYNJ83507, UDI-DI: 10195327273071(each), 40195327273072(case), Lot Number: 24JBX835; 11) DYNJ83248, UDI-DI: 10195327248383(each), 40195327248384(case), Lot Number: 24KBF051; 12) DYNJ81281, UDI-DI: 101953

code_info

1) MNS13635A, UDI-DI: 10653160994244(each), 40653160994245(case), Lot Number: 24IBH747; 2) DYNJ81281, UDI-DI: 101953271…

1) MNS13635A, UDI-DI: 10653160994244(each), 40653160994245(case), Lot Number: 24IBH747; 2) DYNJ81281, UDI-DI: 10195327103620(each), 40195327103621(case), Lot Number: 24JBM309; 3) OBK387M, UDI-DI: 10889942686810(each), 40889942686811(case), Lot Number: 24JBM385; 4) DYNJ81281, UDI-DI: 10195327103620(each), 40195327103621(case), Lot Number: 24JBM576; 5) DYNJ40573A, UDI-DI: 10888277988514(each), 40888277988515(case), Lot Number: 24JBM871; 6) CDS983998C, UDI-DI: 10193489776713(each), 40193489776714(case), Lot Number: 24JBS915; 7) DYNJ64300A, UDI-DI: 10193489852370(each), 40193489852371(case), Lot Number: 24JBU461; 8) DYNJ55205, UDI-DI: 10889942532803(each), 40889942532804(case), Lot Number: 24JBV449; 9) DYNJ56550, UDI-DI: 10889942671779(each), 40889942671770(case), Lot Number: 24JBV561; 10) DYNJ83507, UDI-DI: 10195327273071(each), 40195327273072(case), Lot Number: 24JBX835; 11) DYNJ83248, UDI-DI: 10195327248383(each), 40195327248384(case), Lot Number: 24KBF051; 12) DYNJ81281, UDI-DI: 101953

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-1614-2025%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.