Medline medical convenience kits — Class I medical device recall Z-2148-2026
Ongoing recall by Medline Industries, LP, reported 2026-05-20, distributed nationwide. Medline has identified the presence of particulate within the fluid path of the Manifolds.
| Recall number | Z-2148-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-03-24 |
| Classified | 2026-05-08 |
| Reported by FDA | 2026-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 107 kits |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 10193489475135, 40193489475136 |
| Lot numbers | 23GBR742, 23IBC951, 23JBM554, 23LBK506, 24BBO670, 24GBM624 |
Product
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
Reason for recall
Medline has identified the presence of particulate within the fluid path of the Manifolds.
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-2148-2026. 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.