Quick Facts at a Glance
- Recall Date
- January 5, 2026
- Hazard Level
- HIGH
- Brand
- Medline Industries, LP
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medline Industries, LP
- Product type
- Wound Wash Kit
- Model numbers
- 1) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25BBO366, 2) DYKM1528, Lot Number: 25ABI804, 3) DYKM1528, Lot Number: 25ABF375 +4 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 5, 2026
Reported by FDA DEVICE
March 4, 2026
RecallRadar source check
March 11, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
About This Product
The Medline Nail Kit is designed for wound care, featuring sterile saline for irrigation. Consumers purchase these kits for home first aid or professional medical use.
Why This Is Dangerous
The sterility assurance failure means that the saline solution may contain harmful microorganisms. This increases the risk of infection when used on wounds.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers should stop using the product to avoid potential infections. The recall may cause inconvenience, but it is essential for safety.
Practical Guidance
How to identify if yours is affected
- Locate the model number DYKM1528 on the product.
- Check the lot numbers against the affected list: 25BBO366, 25ABI804, 25ABF375, 24JBL155, 24IBG900.
- Confirm the distribution date of the product to ensure it falls within the recall period.
Where to find product info
Look for the model number and lot number on the packaging or the product itself, usually printed on a label.
What timeline to expect
Refund processing typically takes 4-6 weeks after the return is received.
If the manufacturer is unresponsive
- Contact Medline customer service again.
- Document all correspondence and attempts to resolve the issue.
- Consider filing a complaint with the FDA if issues persist.
How to prevent similar issues
- Always verify the sterility of medical products before use.
- Purchase medical supplies from reputable sources with clear safety certifications.
- Be aware of recalls in your medical supplies regularly.
Documentation advice
Keep records of your purchase, any correspondence with the manufacturer, and photos of the product.
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Product Details
The affected product is the Medline Nail Kit, Model Number DYKM1528, distributed worldwide, including the U.S., Bahamas, Bermuda, and Cayman Islands. The recall affects 8,773 units sold since the product was made available.
Key Facts
- Model Number: DYKM1528
- Quantity recalled: 8,773 units
- Recall date: January 5, 2026
- Hazard: Sterility assurance failure
- Distribution: Worldwide, including the U.S.
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Safety Guide
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