Medline Convenience Kits containing select SKUs of 10mL Polycarbonate… — Class II medical device recall Z-1892-2026
Ongoing recall by Medline Industries, LP, reported 2026-04-29, distributed nationwide. Unapproved design changes to the products outside of the 510(k) clearance.
| Recall number | Z-1892-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-02-27 |
| Classified | 2026-04-17 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB, CA, PA |
| Quantity | 270,311 total |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 10193489761689, 10195327547127, 40193489761680, 40195327547128 |
| Lot numbers | 24ABS765, 24ABT556, DYNJ41792G |
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYNJ41792G
Reason for recall
Unapproved design changes to the products outside of the 510(k) clearance.
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-1892-2026. 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.