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.
What this means for you
Illness, injury, or structural failure has been reported. 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
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.
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