Medline Convenience Kits containing BD ChloraPrep Clear — Class II medical device recall Z-3078-2026
Ongoing recall by Medline Industries, LP, reported 2026-09-09, distributed nationwide. Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the ma
| Recall number | Z-3078-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-07-20 |
| Classified | 2026-08-31 |
| Reported by FDA | 2026-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 222,653 total |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10198459146640 |
| Lot numbers | 24KBP388 |
Product
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3078-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.