HIGH

Medline Recalls Wound Wash Kits Over Sterility Concerns

Medline Industries recalled 8,773 units of its Nail Kit, Model Number DYKM1528, on January 5, 2026. The recall stems from a failure to meet required sterility assurance levels in the saline wound wash. Patients and healthcare providers should stop using the product immediately.

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

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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

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

  1. Locate the model number DYKM1528 on the product.
  2. Check the lot numbers against the affected list: 25BBO366, 25ABI804, 25ABF375, 24JBL155, 24IBG900.
  3. 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.

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.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
1) DYKM1528
UDI-DI: 10889942689927(each)
40889942689928(case)
Lot Number: 25BBO366
2) DYKM1528
+7 more
Affected States
ALL
Report Date
March 4, 2026
Recall Status
ACTIVE

Related Recalls

Vehicles & Parts
HIGH

Mazda CX-70 Recall 2025 for Powertrain Control Module Software May Lose Drive Power

Mazda North American Operations is recalling 2024 CX-90 and 2025 CX-70 SUVs sold through Mazda dealers. The PCM and ECM software can illuminate malfunction indicator lights and cause a loss of drive power, increasing crash risk. Owner notification letters were mailed December 19, 2024, and Mazda will reprogram the PCM and ECM at no charge.

Mazda
Loss of
Read more
Vehicles & Parts
HIGH

Nissan Kicks 2025 Certification Label Recall for GVWR/GAWR Errors (PD136, PMA47)

Nissan North America is recalling certain 2025 Nissan Kicks vehicles sold through Nissan dealers nationwide. The certification label may print incorrect GVWR and GAWR values, risking overload. Some SR trims with a 19-inch wheel package may display an incorrect wheel size on the label, and owners should contact their Nissan dealer to arrange replacement labels.

Nissan
An overloaded
Read more