Medline Industries Recalls Nail Kits Due to Potential Sterility Issues in Wound Wash
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 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.
Source: FDA Official Notice