Data Foundry

Medical device recalls 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate… — Class II medical device recall Z-1876-2026

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 numberZ-1876-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedline Industries, LP, Northfield, IL, United States
Recall initiated2026-02-27
Classified2026-04-17
Reported by FDA2026-04-29
DistributedNationwide (US)
Countries outside the USBB, CA, PA
Quantity270,311 total
Reason classesunapproved product
UPC / GTIN / UDI-DI10193489368321, 10193489368888, 10193489604337, 10193489674910, 10193489747621, 10193489765519, 10193489853643, 10193489859485, 10888277012042, 10889942054688, 10889942122820, 10889942138630, 10889942214495, 40193489368322, 40193489368889, 40193489604338, 40193489674911, 40193489747622, 40193489765510, 40193489853644, 40193489859486, 40888277012043, 40889942054689, 40889942122821, 40889942138631 and 1 more
Lot numbers20ADA585, 20BBL115, 20BBR301, 20CBA649, 20CBI049, 20DBB933, 20DBP595, 20EBB600, 20FBK900, 20GBD331, 20GBL795, 20HBW939, 20IBC788, 20IMA683, 20JBM786, 20KBF148, 20KBI815, 21ABB348, 21ABK039, 21ABK542, 21ABR327, 21AMB131, 21BBK244, 21BMB923, 21BMC128, 21BMC467, 21CBL359, 21CBM120, 21CMC052, 21CMD384, 21DBQ397, 21DLA453, 21DMA301, 21DMD441, 21DMD929, 21EBR327, 21EMB686, 21FBE618, 21FBM873, 21FLA083 and 186 more

Product

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK DYNJ32555C, DYNJ66631 ANGIO TRAY DYNJ46153B ANGIOGRAPHY PACK DYNJ26855F ANGIOGRAPHY PACK-M-LF DYNJ24530I ANGIOGRAPHY TRAY-LF DYNJ0220880V, DYNJ30077D CATH LAB ANGIO PACK-LF DYNJ0545064X CATH LAB PACK DYNJ39057C FEMORAL ANGIOGRAPY SET UP DYNJ61015B RAD-ANGIO PACK DYNJ47710C SURGERY ANGIO PACK-LF PHS677784013A

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-1876-2026. 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.