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

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.

The Hazard

The manufacturer of the sterile saline wound wash used in these kits may not have achieved the minimum required sterility assurance level. This defect poses a high risk of infections and other complications.

Reported Incidents

There are no reported injuries or incidents associated with this recall at this time. Consumers are urged to take precautionary measures.

What to Do

Stop using the Medline Nail Kit immediately. Follow the recall instructions provided by Medline and contact the manufacturer or your healthcare provider for further instructions.

Contact Information

For more information, call Medline Industries, LP at 1-800-633-5463 or visit their website at www.medline.com.

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.

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
DYKM1528
UDI-DI: 10889942689927
40889942689928
25BBO366
25ABI804
+3 more
Affected States
ALL
Report Date
March 4, 2026
Recall Status
ACTIVE

Related Recalls

HIGH

AvKARE Recalls Amantadine HCl Capsules Over Dissolution Issues

AvKARE recalled Amantadine HCl capsules on February 13, 2026, due to failed dissolution specifications. The recall affects the 100 mg capsules, which may not dissolve properly. Consumers should stop using this product and contact their healthcare provider immediately.

AMANTADINE HCL
Failed Dissolution
Read more
HIGH

Eptifibatide Injection Recalled Over Labeling Error

Slate Run Pharmaceuticals recalled Eptifibatide Injection on February 12, 2026. The recall affects all lots of the 75 mg/100 mL vial due to incorrect dosing information. Healthcare providers and consumers must stop using the product immediately.

Eptifibatide
Labeling: Not
Read more
HIGH

LEO Pharma Recalls Adbry Injection Over Sterility Concerns

LEO Pharma Inc. recalled 11,407 units of Adbry injection on February 10, 2026. The recall stems from a lack of assurance of sterility due to particulate matter identified as wool fiber. Consumers should stop using the product immediately and contact their healthcare provider for guidance.

ADBRY
Lack of
Read more
HIGH

Hitachi Proton Beam Therapy System Recalled Due to Software Issue

Hitachi recalled its Proton Beam Therapy System on February 6, 2026, due to a software anomaly that may result in positional discrepancies. The recall affects one unit distributed in Texas and Washington D.C. Healthcare providers and patients must stop using the device immediately.

Hitachi
Software anomaly
Read more
HIGH

Fresenius Kabi Vancomycin Injection Recalled Over Sterility Concerns

Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.

Fresenius Kabi Compounding
Lack of
Read more