The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1434-2026·Announced 2026-03-04

Medline Nail Kit Sterile Saline Wound Wash Recall

Medline is recalling 8,773 NAIL KIT (Model DYKM1528) units because the sterile saline wound wash may not have been manufactured to the required sterility assurance level for sterile products.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving a sterile medical device product where the sterility assurance level may not have been met, posing a risk of infection or adverse health consequences from use of a product intended to be sterile.

Plain-English summary

Medline Industries, LP is recalling its NAIL KIT, Model Number DYKM1528, distributed worldwide including US Nationwide and the Bahamas, Bermuda, and Cayman Islands. The recall covers 8,773 units plus an additional 5,940 units added on 3/27/26, across 15 lot numbers plus one additional lot (25IBP134). The affected product is identified by UDI-DI 10889942689927 (each) and 40889942689928 (case). The reason for the recall is that the manufacturer of the sterile saline wound wash included in the kit may not have manufactured the product to meet the minimum required sterility assurance level required for sterile products. This is a Class II recall, meaning use of or exposure to the product may cause temporary adverse health consequences. Consumers who have received the recalled kits should stop using the sterile saline wound wash component and contact Medline for instructions on return or replacement. Healthcare facilities and consumers with questions should reach out to Medline customer service using the contact information provided in the recall notice.

The recalled product

Product
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
Manufacturer
Medline Industries, LP
Category
Medical Device — Sterile Wound Care Kit
Hazard

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) DYKM1528
  • UDI-DI: 10889942689927(each)
  • 40889942689928(case)
  • Lot Number: 25BBO366
  • 2) DYKM1528
  • Lot Number: 25ABI804
  • 3) DYKM1528
  • Lot Number: 25ABF375
  • 4) DYKM1528
  • Lot Number: 24JBL155
  • 5) DYKM1528
  • Lot Number: 24IBG900
  • 6) DYKM1528
  • Lot Number: 24FBT801
  • 7) DYKM1528
  • Lot Number: 24FBC584
  • 8) DYKM1528
  • Lot Number: 24DBB692
  • 9) DYKM1528
  • Lot Number: 24BBL239

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Medline Industries, LP 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.

See all 5 products in this recall →

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