DeviceSignal · Recall classified
Medline Industries, LP
FDA classified a device recall on 2026-08-31 · Class II · Z-3067-2026
EventRecall classified
Effective2026-08-31
ClassificationClass II
On 2026-08-31 the FDA classified a device recall from Medline Industries, LP as Class II. Product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP…. Recall Z-3067-2026. The firm initiated it on 2026-07-20. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3067-2026
- Classification
- Class II
- Classified on
- 2026-08-31
- Initiated on
- 2026-07-20
- Firm
- Medline Industries, LP
- Reason
- Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
- Product
- Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3067-2026- Snapshot hash
2ad9ab6cbee6c5eb2f0d4298731a8c9755893d917528d78bf00a015fa69a0494- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-15T12:38:10.708Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
deb7cc1bd114e5e7a455c9bb463a9dc330ea59852f4358a5451d849dfc7cbca6- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)