Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH — Class II medical device recall Z-3056-2026
Ongoing recall by Medline Industries, LP, reported 2026-09-09, distributed nationwide. The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach o
| Recall number | Z-3056-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-06-12 |
| Classified | 2026-08-31 |
| Reported by FDA | 2026-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 22,736 kits |
| Reason classes | microbial contamination, sterility, packaging |
| UPC / GTIN / UDI-DI | 10195327232924, 10195327407100, 10195327628826, 10198459146794, 10888277797819, 10889942508143, 40195327232925, 40195327407101, 40195327628827, 40198459146795, 40888277797810, 40889942508144 |
| Lot numbers | 23IMI364, 23JBQ286, 23JMG372, 23KBN939, 23LBT913, 24AMB256, 24BBH722, 24BMF851, 24CBB880, 24CBT739, 24CBV226, 24CBV460, 24DBM033, 24DMC055, 24EBR549, 24FMB552, 24GBH769, 24IBL537, 24IMF355, 24JBL006, 24JMG337, 24KMD782, 24KMH747, 24LBM058, 24LBO554, 25ABI946, 25ABV328, 25AMI449, 25BMB196, 25BMI538, 25DBN710, 25KME690 |
| Model numbers | CDS860014P, DYKM1000B, DYKM2187, DYKM2187A, DYNDH1909A, DYNDV1615I |
Product
Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1000B; 3) KIT, I V START NSK, Model Number: DYKM2187; 4) KIT, I V START NSK, Model Number: DYKM2187A; 5) IV BLOOD CULTURE KIT, Model Number: DYNDH1909A; 6) IV START W/EXT SET KIT, Model Number: DYNDV1615I
Reason for recall
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.
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-3056-2026. 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.