Medline medical convenience kits — Class I medical device recall Z-1715-2026
Ongoing recall by Medline Industries, LP, reported 2026-04-15, distributed nationwide. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotatin
| Recall number | Z-1715-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-02-27 |
| Classified | 2026-04-07 |
| Reported by FDA | 2026-04-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, JP, KR, LK, NL, PK, SG, SK |
| Quantity | 1,698 kits |
| UPC / GTIN / UDI-DI | 10193489664263, 10889942405503, 10889942405510, 10889942464722, 10889942611751, 40193489664264, 40889942405504, 40889942405511, 40889942464723, 40889942611752 |
| Lot numbers | 25GBF769, 25GBL070, 25GBL526, 25GBL527, 25GDA142, 25HBN798, 25IBN161, 25IBP989 |
Product
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061; 2. CSTM MANIFOLD KIT - FRYE, Medline SKU VASC1074; 3. CRYO EP MANIFOLD KIT, Medline SKU VASC1198; 4. MANIFOLD KIT - 500PSI OFF, Medline SKU VASCSHPOFF1; 5. MANIFOLD KIT LOW PRESSURE ON, Medline SKU VASCSLPON1.
Reason for recall
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
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-1715-2026. 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.