RecallHawk
Class II Recall

Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ1800

MEDLINE INDUSTRIES, LP - Northfield

Summary

The FDA issued a Class II for Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD, by MEDLINE INDUSTRIES, LP - Northfield. Reason: There is a potential for the sterility of the device to be compromised..

Details

Source

Device Recall

External ID

Z-1530-2025

Action Date

2025-04-16

Status

Ongoing

Category

device

Product Description

Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPURP,10CT 4) Model Number: MJ76126V1, DBD-MEIJER,HYDROCOLLOID,FINGER&TOE,8CT 5) Model Number: RA0353818V1, BANDAGE,BLISTER, RITEAID,6EA/BX, 24BX/CS

Lot/Code Info: 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;

Quantity Affected: 364842 units

Reason for Recall

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

Distribution

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

Type: Voluntary: Firm initiated

Recall Initiated: 2025-02-19

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 140 device recalls issued in the same week, part of 413 device-related FDA actions this month.

MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?

MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1530-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for device

Related Actions