Wayson Hydrocolloid Bandages Recalled Due to Sterility Compromise Risk
Medline Industries is recalling multiple Wayson Hydrocolloid bandage models due to potential compromise of device sterility. The recalled products were distributed nationwide in the US 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source is an FDA Class II recall of a sterile medical device with potential sterility compromise, which presents a risk of harm to patients. The source text does not report any illnesses, injuries, or deaths, so the severity is capped at High per the rubric criterion for risk-of-harm products without reported adverse events.
Plain-English summary
Medline Industries, LP is recalling Wayson Hydrocolloid bandages in multiple models: CUR5103, MJ18004, MJ18005, MJ76126V1, and RA0353818V1. A total of 364,842 units have been recalled. These sterile hydrocolloid bandages are used for wound care and blister treatment.
The recall is due to a potential for the sterility of the device to be compromised. The affected products were distributed worldwide, including nationwide distribution in the United States and international distribution to Bermuda, Canada, Panama, and Singapore.
Consumers and healthcare providers who have these recalled bandages should discontinue use. Affected lot numbers are identified in the FDA recall notice Z-1530-2025. Users should contact Medline Industries or consult with their healthcare provider regarding replacement or alternative wound care products.
The recalled product
- Product
- 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…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 364,842
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) CUR5103
- UDI-DI: 00888277307400(each)
- 40888277307408(case)
- Lot Number: 10315040001
- 2) CUR5103
- Lot Number: 10317020005
- 3) CUR5103
- Lot Number: 10317030004
- 4) CUR5103
- Lot Number: 10317120001
- 5) CUR5103
- Lot Number: 10318050003
- 6) CUR5103
- Lot Number: 10318070002
- 7) CUR5103
- Lot Number: 10318080003
- 8) CUR5103
- Lot Number: 10319010004
- 9) CUR5103
- Lot Number: 10319050004
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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