FDA Device recall Z-3078-2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A
- FDA Device
- Class II
- ongoing
- Published 2026-09-09
On 2026-09-09 the FDA classified a Class II recall of Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A by Medline Industries, citing 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 ap….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3078-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-20 |
| Published | 2026-09-09 |
| Last updated | 2026-09-23 05:30 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A
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.
Identifiers
| code_info | DYKS1583A UDI-DI 10198459146640 Lot 24KBP388 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-15 05:30 UTC. Current status: ongoing.
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FDA Device · Class I · 2026-10-07 · Medline Industries - Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E MDR520094 PENDANT F/…
FDA Device · Class I · 2026-10-07 · Medline Industries - Medline convenience kits containing Healthmark Instrument Channel Brushes
FDA Device · Class II · 2026-09-30 · Medline Industries - Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I
FDA Device · Class II · 2026-09-30 · Medline Industries - Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197
FDA Device · Class II · 2026-09-30 · Medline Industries
All Medline Industries recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3078-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.