Wayson Hydrocolloid Bandages recalled due to sterility concerns
Medline Industries is recalling Wayson Hydrocolloid Bandages because the sterility of the devices may be compromised. Affected products include multiple models distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a potential sterility compromise, which is theoretical without evidence of harm, placing this in the Moderate category per the rubric for low-risk or precautionary recalls with no reported adverse events.
Plain-English summary
Medline Industries, LP is recalling Wayson Hydrocolloid Bandages due to a potential compromise in device sterility. The affected products include the MJ Bandage Hydrocolloid Heel Oval 6CT (Model MJ18004V2), MJ Bandage Hydrocolloid All Purpose 10CT (Model MJ18005V2), MJ Bandage Hydrocolloid Finger Toe 8CT (Model MJ76126V2), and Walmart-branded hydrocolloid bandages (Models WAL1901 and WAL1902). A total of 1,894,488 units have been distributed.
The products were distributed nationwide in the United States and to Bermuda, Canada, Panama, and Singapore. Specific lot numbers are identified in the FDA recall notice and are available through the manufacturer and FDA website.
Consumers should stop using these bandages immediately and consult their healthcare provider if they have used an affected product. Retailers and healthcare facilities should identify and quarantine recalled inventory by matching product model numbers and lot numbers to the FDA recall list.
The recalled product
- 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…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 1,894,488
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) MJ18004V2
- UDI-DI: 00708820656963(each)
- 20708820656967(case)
- Lot Number: 10324070002
- 2) MJ18004V2
- Lot Number: 10324110002
- 3) MJ18004V2
- Lot Number: 10324120004
- 4) MJ18005V2
- UDI-DI: 00708820656970(each)
- 20708820656974(case)
- Lot Number: 10324090005
- 5) MJ18005V2
- 6) MJ76126V2
- UDI-DI: 00708820502734(each)
- 40708820502732(case)
- 7) MJ76126V2
- Lot Number: 10324090003
- 8) MJ76126V2
- 9) WAL1901
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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