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FDA Medical Device Recalls (openFDA)

MEDLINE INDUSTRIES, LP - Northfield: 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;

Recall number
Z-1531-2025
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
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;
Status
Open, Classified
Initiated
2025-02-19
Posted
2025-04-04
Terminated
not on file
Reason
There is a potential for the sterility of the device to be compromised.
Root cause
Under Investigation by firm
Action
An "URGENT MEDICAL DEVICE RECALL" notification letter dated 2/19/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3.Please destroy any affected inventory. Medline will issue credit for the product based upon the quantity and lot numbers identified on the submitted response form The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-25-026 Recall Code: Recall Code 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers document and destroy any affected product, and include your customer s quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity
1894488 units
Distribution
Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Bermuda, Canada, Panama, Singapore
Lot, serial or model codes
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;
510(k) numbers
not on file
PMA numbers
not on file
Product code
NAD
Firm FEI
1417592
Firm city
Northfield
Firm state
IL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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