CLASS II ONGOING Device recall · Reported 4 Mar 2026 · FDA Enforcement Report
Medline Convenience Kits: NAIL KIT recalled by Medline Industries
Medline Industries is recalling Medline Convenience Kits: NAIL KIT, distributed nationwide in the US. The recall was initiated on 5 Jan 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1432-2026
- FDA event ID
- 98319
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Jan 2026
- FDA classified
- 20 Feb 2026
- Reported
- 4 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 5 Jan 2026 | Recall initiated by company | |
| 20 Feb 2026 | Classified by FDA | +46 days |
| 4 Mar 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
1) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 25CBS147; 2) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 25CBJ329; 3) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 25ABU209; 4) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 24DBJ364; 5) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 24DBB718; 6) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 23JBV524; 7) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 23IBU998; 8) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 23IBF119
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 98319This product is part of a recall event; the main page for the event is Medline Convenience Kits: NAIL KIT recalled by Medline Industries.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medline Convenience Kits: NAIL KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide | |
| CLASS II | Meijer Sterile saline wound wash, First Aid Cleansing Spray recalled | Medline Industries | Sterility | Nationwide | |
| CLASS II | Medline Sterile Saline Wound Wash recalled by Medline Industries | Medline Industries | Sterility | Nationwide | |
| CLASS II | Medline Convenience Kits: Trunk KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
More recalls from Medline Industries
All 726| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline surgical convenience kits labeled as: EAR recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline surgical convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide |
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