Z-1531-2025Class II

Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE...

Name: Z-1531-2025 Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2025-02-19
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-02-19 / Open, Classified / root cause: sterility

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOLLOID ALL PURP 10CT, Model Number... on 2025-02-19. FDA classified it as Class II and gives the reason as "There is a potential for the sterility of the device to be compromised". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1531-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-19
Posted: 2025-04-04
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;
Product code: NAD Dressing, Wound, Occlusive
Reason for recall: There is a potential for the sterility of the device to be compromised.
Root cause tag: sterility
FDA 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 [email protected].
Quantity in commerce: 1894488 units
Distribution: Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Bermuda, Canada, Panama, Singapore
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1531-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1530-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-16	2025-04-04
Z-1531-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-16	2025-04-04

Product code NAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)