FDAClass IIApril 16, 2025

Wayson Hydrocolloid recall: Sterility Concern

Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004…

Why was Wayson Hydrocolloid recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

1) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10315040001; 2) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10317020005; 3) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10317030004; 4) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10317120001; 5) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10318050003; 6) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10318070002; 7) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10318080003; 8) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319010004; 9) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319050004; 10) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319060001; 11) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319110002; 12) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319110004; 13) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320030005; 14) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320050002; 15) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320080001; 16) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320080002; 17) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320100001; 18) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320100002; 19) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321030001; 20) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321040007; 21) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321050003; 22) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321050004; 23) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321090002; 24) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321110002; 25) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10322070004; 26) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10322080003; 27) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10323030001; 28) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10323030003; 29) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10323070001; 30) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10323080006; 31) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10323090005; 32) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10324010006; 33) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10324040002; 34) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10324070001; 35) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10324090004; 36) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10319020001; 37) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10319050005; 38) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10319080004; 39) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10319100004; 40) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10320030003; 41) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10320080001; 42) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10320090003; 43) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321010004; 44) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321020001; 45) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321030001; 46) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321040005; 47) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321050006; 48) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321070003; 49) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321080004; 50) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321090005; 51) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321090006; 52) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321100001; 53) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321100006; 54) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10322020002; 55) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10322090003; 56) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10322110002; 57) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10323030003; 58) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10323060001; 59) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10323080001; 60) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10323090002; 61) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10323110003; 62) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10324020001; 63) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10319020001; 64) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10319050005; 65) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10319080003; 66) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10319120004; 67) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10320040002; 68) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10320070003; 69) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10320090001; 70) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321010001; 71) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321010004; 72) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321020001; 73) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321030001; 74) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321030004; 75) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321050006; 76) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321070003; 77) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321070004; 78) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321080005; 79) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321100001; 80) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321100005; 81) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10322010001; 82) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10322020002; 83) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10322030001; 84) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10322100001; 85) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10322120002; 86) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10323030003; 87) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10323040001; 88) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10323080001; 89) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10323100003; 90) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10324020002; 91) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319020001; 92) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319050003; 93) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319070003; 94) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319080001; 95) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319110001; 96) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319120001; 97) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10320070001; 98) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10320070003; 99) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10320090004; 100) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10320110001; 101) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10320120004; 102) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321010002; 103) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321010004; 104) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321020001; 105) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321030001; 106) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321070003; 107) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321070004; 108) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321080005; 109) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321090001; 110) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321090007; 111) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321100001; 112) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321100002; 113) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321100005; 114) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322020002; 115) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322080003; 116) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322080004; 117) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322090001; 118) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322090002; 119) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322100001; 120) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322120002; 121) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323010002; 122) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323030004; 123) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323060001; 124) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323070003; 125) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323080006; 126) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323090005; 127) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323100003; 128) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324010001; 129) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324010006; 130) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324030004; 131) RA0353818V1, UDI-DI: 00011822538183(each), 40011822538181(case), Lot Number: 10323080007; 132) RA0353818V1, UDI-DI: 00011822538183(each), 40011822538181(case), Lot Number: 10323090004; 133) RA0353818V1, UDI-DI: 00011822538183(each), 40011822538181(case), Lot Number: 10323090005; 134) RA0353818V1, UDI-DI: 00011822538183(each), 40011822538181(case), Lot Number: 10323100002; 135) RA0353818V1, UDI-DI: 00011822538183(each), 40011822538181(case), Lot Number: 10324010006;

Product
Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
364842 units
Distribution
Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Bermuda, Canada, Panama, Singapore
Recall date
April 16, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls