FDA Medical devices recall ·
Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT… recall
- Recall number
- Z-1531-2025
- Date
- (initiated February 19, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1894488 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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;
Why was it recalled?
There is a potential for the sterility of the device to be compromised.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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), 2068113128
Distribution
Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Bermuda, Canada, Panama, Singapore
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1531-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.