Convenience kits containing select SKUs of 10mL Polycarbonate Colored… — Class II medical device recall Z-2591-2026
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-2591-2026 |
|---|---|
| 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 |
| Quantity | 113,843 kits |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 10193489329940, 10193489342581, 10193489343281, 10193489448917, 10193489634594, 10193489833416, 10193489838404, 10193489854886, 10193489854893, 10193489864199, 10193489891263, 10884389648216, 10889942165704, 10889942185863 |
| Lot numbers | 20XBH471, 21ADA204, 21AMA053, 21BBC325, 21CBE250, 21CBF463, 21CBX084, 21CDA555, 21CDB566, 21CME104, 21DBP668, 21DBR247, 21DDA694, 21DDA970, 21EDB249, 21EDB709, 21EME408, 21FBB546, 21FBC416, 21FLA468, 21FMD506, 21FMF601, 21GBL506, 21GDC532, 21GDD164, 21GMG028, 21HBD075, 21HDC041, 21HLA726, 21HMF637, 21HMG835, 21IBO920, 21IDA472, 21IMC537, 21JBS587, 21JDB401, 21JDC566, 21JMF531, 21JMF774, 21KBN509 and 30 more |
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY PACK DYNJ44293D ANGIOGRAPHY PACK-LF DYNJ0854485T DYNJ35916J GENERAL ANGIO PACK DYNJ57760B GENERAL ENDO PACK-LF DYNJ0842873J JUDKINS PACK DYNJ51126A RADIOLOGY ANGIO MAJOR PACK DYNJ62858B TAVR JUDKINS PACK DYNJ51127B
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-2591-2026. 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.