DeviceSignal · Recall classified
Medline Industries, LP
FDA classified a device recall on 2026-08-31 · Class II · Z-3074-2026
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 DELUXE PRE…. Recall Z-3074-2026. The firm initiated it on 2026-07-20. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3074-2026
- Classification
- Class II
- Classified on
- 2026-08-31
- Initiated on
- 2026-07-20
- Firm
- Medline Industries, LP
- Reason
- 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.
- Product
- Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP KIT DYKM1398B
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-3074-2026- Snapshot hash
e8e634c086f9f5f52e82a7eef6331d8800209bbb8cbb79bd654d29f1222caae4- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-23T12:43:31.676Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
db5288df342707b11600ec17705d0d040d940ffc591a7df7ede2a8df6559ad1d- 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)