Medline Industries Recalls Nail Kits Due to Potential Sterility Issues in Wound Wash

Source: FDA · United States

According to the U.S. Census Bureau's American Community Survey (ACS) 5-year estimates, the CDC PLACES population-level health analysis, and the CMS Hospital Compare quality data, Areazine publishes editorial articles drawing on more than 19,000 U.S. city profiles. See our methodology for full source attribution and refresh cadence.

Medline Industries, LP has voluntarily recalled over 8,700 nail kits because the included sterile saline wound wash may not meet required sterility assurance levels.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on March 10, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, MedicalDevice) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Medline Industries, LP has initiated a voluntary recall of its Medline Convenience Kits (Nail Kits) after identifying that the manufacturer of the sterile saline wound wash included in the kits may not have met the minimum sterility assurance levels required for sterile products. This Class II recall was initiated by the firm via letter on January 5, 2026.

Which Products Are Affected

The recall affects 8,773 units of the Medline Convenience Kits: NAIL KIT, specifically Model Number: DYKM1528. The affected products were distributed worldwide, including throughout the United States, the Bahamas, Bermuda, and the Cayman Islands.

The following lot numbers are included in this recall:

  • 25BBO366
  • 25ABI804
  • 25ABF375
  • 24JBL155
  • 24IBG900
  • 24FBT801
  • 24FBC584
  • 24DBB692
  • 24BBL239
  • 23KBO692
  • 23IBT788
  • 23HBJ026
  • 23EBK780
  • 23DBL149
  • 23CBJ576

UDI-DI Information:

  • Each: 10889942689927
  • Case: 40889942689928

What You Should Do

Consumers and healthcare facilities should immediately check their inventory for the affected lot numbers listed above. If you possess recalled kits, you should follow the instructions provided in the notification letter sent by Medline Industries. For more information regarding the return or replacement process, contact Medline Industries, LP at their Northfield, Illinois headquarters.

Why This Matters

When medical products intended to be sterile do not meet sterility assurance levels, there is an increased risk of infection for patients. This recall ensures that potentially compromised wound wash components are removed from use to maintain patient safety.

Source

This information is sourced from the FDA under recall number Z-1434-2026.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries, LP has voluntarily recalled over 8,700 nail kits because the included sterile saline wound wash may not meet required sterility assurance levels.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.