CLASS II ONGOING Device recall · Reported 16 Apr 2025 · FDA Enforcement Report

Wayson Hydrocolloid recalled by MEDLINE INDUSTRIES, LP

Medline Industries LP - Northfield is recalling Wayson Hydrocolloid, distributed nationwide in the US. The recall was initiated on 19 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) 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) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10320010001; 13) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10320040001; 14) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10320060002; 15) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10320100001; 16) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10320110002; 17) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10320120003; 18) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321010002; 19) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321010005; 20) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321020003; 21) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321030004; 22) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321040003; 23) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321040005; 24) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321040007; 25) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321050006; 26) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321090002; 27) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321100002; 28) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321110004; 29) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321110005; 30) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321110007; 31) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321120006; 32) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322010004; 33) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322030003; 34) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322030004; 35) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322040004; 36) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322050001; 37) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322060001; 38) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322070004; 39) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322080003; 40) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322090002; 41) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322090003; 42) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322090004; 43) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322110002; 44) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10323010001; 45) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10323030001; 46) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10323030003; 47) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10323040001; 48) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10323080001; 49) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10323090002; 50) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10324030007; 51) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10324060004; 52) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10324070005; 53) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10324080003; 54) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10319100003; 55) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10319110002; 56) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10319110004; 57) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10320010001; 58) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10320110001; 59) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10320120003; 60) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10320120004; 61) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321010005; 62) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321020003; 63) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321030004; 64) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321040003; 65) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321040005; 66) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321040007; 67) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321060003; 68) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321070007; 69) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321080005; 70) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321090005; 71) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321100006; 72) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321110005; 73) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321110007; 74) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321120006; 75) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322010004; 76) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322030004; 77) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322040004; 78) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322050002; 79) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322060004; 80) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322070004; 81) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322080001; 82) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322090003; 83) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322100001; 84) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322110004; 85) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10323030001; 86) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10323030003; 87) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10323060003; 88) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10323080005; 89) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10323120002; 90) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10324060002; 91) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10324070006;

Quantity recalled1894488 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1531-2025
FDA event ID: 96425
Recalling firm: Medline Industries LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 19 Feb 2025
FDA classified: 4 Apr 2025
Reported: 16 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

19 Feb 2025	Recall initiated by company
4 Apr 2025	Classified by FDA	+44 days
16 Apr 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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;

Where it was distributed

Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Bermuda, Canada, Panama, Singapore

Nationwide

Stores named: Walmart

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10320010001; 13) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10320040001; 14) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10320060002; 15) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10320100001; 16) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10320110002; 17) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10320120003; 18) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321010002; 19) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321010005; 20) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321020003; 21) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321030004; 22) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321040003; 23) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321040005; 24) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321040007; 25) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321050006; 26) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321090002; 27) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321100002; 28) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321110004; 29) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321110005; 30) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321110007; 31) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10321120006; 32) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322010004; 33) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322030003; 34) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322030004; 35) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322040004; 36) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322050001; 37) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322060001; 38) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322070004; 39) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322080003; 40) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322090002; 41) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322090003; 42) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322090004; 43) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10322110002; 44) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10323010001; 45) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10323030001; 46) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10323030003; 47) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10323040001; 48) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10323080001; 49) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10323090002; 50) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10324030007; 51) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10324060004; 52) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10324070005; 53) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10324080003; 54) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10319100003; 55) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10319110002; 56) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10319110004; 57) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10320010001; 58) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10320110001; 59) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10320120003; 60) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10320120004; 61) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321010005; 62) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321020003; 63) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321030004; 64) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321040003; 65) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321040005; 66) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321040007; 67) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321060003; 68) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321070007; 69) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321080005; 70) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321090005; 71) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321100006; 72) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321110005; 73) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321110007; 74) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10321120006; 75) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322010004; 76) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322030004; 77) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322040004; 78) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322050002; 79) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322060004; 80) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322070004; 81) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322080001; 82) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322090003; 83) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322100001; 84) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10322110004; 85) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10323030001; 86) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10323030003; 87) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10323060003; 88) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10323080005; 89) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10323120002; 90) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10324060002; 91) WAL1902, UDI-DI: 00681131286305(each), 20681131286309(case), Lot Number: 10324070006;

Where was it sold?

Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Bermuda, Canada, Panama, Singapore

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 96425

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025	CLASS II	Wayson Hydrocolloid recalled by MEDLINE INDUSTRIES, LP	Medline Industries LP - Northfield	Sterility	Nationwide

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Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide