Convenience kits containing select SKUs of 10mL Polycarbonate Colored… — Class II medical device recall Z-2593-2026
Ongoing recall by Medline Industries, LP, reported 2026-07-01, distributed nationwide. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products n
| Recall number | Z-2593-2026 |
|---|---|
| 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 | 2026-06-25 |
| Reported by FDA | 2026-07-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 10193489269000, 10193489308099, 10193489381931, 10193489449839, 10193489470321, 10193489473889, 10193489693386, 10193489899603, 10193489925326, 10193489928358, 10193489941906, 10193489950373, 10195327050559, 10195327062545, 10195327101336, 10195327201371, 10195327279028, 10195327286613, 10195327359362, 10195327416027, 10195327477240, 10195327487027, 10195327630904, 10195327637378 |
| Lot numbers | 21ABT991, 21BMB927, 21CBB992, 21CBN901, 21CDC066, 21DBA936, 21EDB518, 21FBE790, 21FBM858, 21FLA630, 21GBE705, 21GBO405, 21GBR992, 21GDC932, 21GLA415, 21GMA692, 21HBL486, 21HBN274, 21HDC814, 21HLA270, 21IMH791, 21JBX464, 21JBX734, 21JLA166, 21KBA699, 21KBP057, 21KLA318, 21LBO216, 22BBB434, 22BBL073, 22BBS266, 22BDA495, 22CBP195, 22CBT553, 22CBT556, 22CLA057, 22CLA817, 22DBT712, 22DDB731, 22DDC457 and 82 more |
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ABDOMINAL VASCULAR-LF DYNJ905291B DYNJ905291C ARTERIOGRAM DYNJ28082G CVICU HEART BAG DYKM2130A ENDOVASCULAR PACK DYNJ0678934J EP PACK DYNJ23456J GENERAL ENDO PACK-LF DYNJ0842873K HYBRID PACK DYNJ65925B DYNJ65925C NON VASCULAR PACK DYNJ68037 PACEMAKER DYNJ901681D PACEMAKER PACK DYNJ51853C DYNJ51853D DYNJ60606A PACER PACK DYNJ40952A RADIOLOGY VASCULAR ACCESS TRAY DYNJVB1303A SM- INTERVENTIONAL DRAPE PK-LF DYNJ0780143K VASCULAR ACCESS PACK-LF DYNJ0101291D VASCULAR DSC DYNJ69172 DYNJ69172B VASCULAR HYBRID DYNJ57543F DYNJ57543I DYNJ57543J VASCULAR PACK DYNJ61702A
Reason for recall
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
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-2593-2026. 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.