FDA Device recall Z-3050-2026
Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414
- FDA Device
- Class II
- ongoing
- Published 2026-09-09
On 2026-09-09 the FDA classified a Class II recall of Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414 by Medline Industries, citing the kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding wh….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3050-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-12 |
| Published | 2026-09-09 |
| Last updated | 2026-09-15 05:30 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog Number: DYKM1414; 3) DYNDH1462A, Catalog Number: DYNDH1462A; 4) DYNJ38145F, Catalog Number: DYNJ38145F; 5) DYNJ63199A, Catalog Number: DYNJ63199A
Reason
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.
Identifiers
| code_info | 1) DYKM1414, UDI-DI: 10889942481293(each), 40889942481294(case), Lot Number: 25BBB327; 2) DYKM1414, UDI-DI: 10889942481…1) DYKM1414, UDI-DI: 10889942481293(each), 40889942481294(case), Lot Number: 25BBB327; 2) DYKM1414, UDI-DI: 10889942481293(each), 40889942481294(case), Lot Number: 24KBE261; 3) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24ABC301; 4) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24ABT704; 5) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24BBO246; 6) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24BBU663; 7) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24CBJ141; 8) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23JBH263; 9) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23JBO539; 10) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23KBG333; 11) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23KBV434; 12) DYNDH1462A, UDI-DI: |
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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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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3050-2026%22
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