CLASS II ONGOING Device recall · Reported 9 Sep 2026 · FDA Enforcement Report
Medline Convenience Kits containing BD ChloraPrep Clear recalled
Medline Industries is recalling Medline Convenience Kits containing BD ChloraPrep Clear - Applicators PAIN PRE OP KIT, distributed nationwide in the US. The recall was initiated on 20 Jul 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-3067-2026
- FDA event ID
- 99561
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Jul 2026
- FDA classified
- 31 Aug 2026
- Reported
- 9 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 20 Jul 2026 | Recall initiated by company | |
| 31 Aug 2026 | Classified by FDA | +42 days |
| 9 Sep 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Medline Convenience Kits containing BD ChloraPrep Clear - Applicators PAIN PRE OP KIT recalled?
Yes. Medline Industries recalled Medline Convenience Kits containing BD ChloraPrep Clear - Applicators PAIN PRE OP KIT on 20 Jul 2026. The recall is Class II and its status is Ongoing. Recall number Z-3067-2026.
Why was it recalled?
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Which lots are affected?
UDI-DI 10198459362835 Lots 25IBJ918 25KBN677 25LBU066 26BBD775
Where was it sold?
US Nationwide distribution.
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 22 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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