FDA Device recall Z-1531-2025

Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2

FDA Device
Class II
ongoing
Published 2025-04-16

On 2025-04-16 the FDA classified a Class II recall of Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2 by Medline Industries Northfield, citing there is a potential for the sterility of the device to be compromised.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1531-2025
Classification	Class II
Status	ongoing
Initiated	2025-02-19
Published	2025-04-16
Last updated	2026-09-13 11:57 UTC
Company	Medline Industries Northfield
Distribution	US

Product

Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOLLOID ALL PURP 10CT, Model Number: MJ18005V2; 3) MJ BNDG HYDROCOLLOID FINGER TOE 8CT, Model Number: MJ76126V2; 4) WALMART,BANDAGE,HYDROCOLLOID,HEEL,6CT, Model Number: WAL1901; 5) WALMART,HYDROCOLLOID,TOE,8CT, Model Number: WAL1902;

Reason

There is a potential for the sterility of the device to be compromised.

Identifiers

code_info	1) MJ18004V2, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10324070002; 2) MJ18004V2, UDI-DI: 007088… 1) MJ18004V2, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10324070002; 2) MJ18004V2, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10324110002; 3) MJ18004V2, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10324120004; 4) MJ18005V2, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10324090005; 5) MJ18005V2, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10324120004; 6) MJ76126V2, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324070002; 7) MJ76126V2, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324090003; 8) MJ76126V2, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324110002; 9) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10319100003; 10) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10319110002; 11) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10319110004; 12)

code_info

1) MJ18004V2, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10324070002; 2) MJ18004V2, UDI-DI: 007088…

1) MJ18004V2, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10324070002; 2) MJ18004V2, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10324110002; 3) MJ18004V2, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10324120004; 4) MJ18005V2, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10324090005; 5) MJ18005V2, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10324120004; 6) MJ76126V2, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324070002; 7) MJ76126V2, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324090003; 8) MJ76126V2, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324110002; 9) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10319100003; 10) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10319110002; 11) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10319110004; 12)

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-1531-2025%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.