Convenience kits containing select SKUs of 10mL Polycarbonate Colored… — Class II medical device recall Z-2592-2026
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-2592-2026 |
|---|---|
| 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 | 10193489268676, 10193489306019, 10193489346978, 10193489364262, 10193489436068, 10193489808810, 10193489876079, 10193489895728, 10193489905205, 10193489925302, 10193489933598, 10193489949452, 10193489952827, 10193489952834, 10193489976618, 10193489978384, 10195327004743, 10195327042776, 10195327096885, 10884389625583, 10884389625606, 10888277065475, 10888277546035, 10889942632794 |
| Lot numbers | 20LMF752, 21ABD076, 21ABG127, 21ABH085, 21ABI181, 21ABN379, 21ABN806, 21ABV975, 21AMD830, 21BBO277, 21BBP110, 21BMB938, 21CBU091, 21CBU277, 21DBL217, 21DBP810, 21DMB287, 21DME914, 21EBA810, 21EBS784, 21EMF097, 21FBH595, 21FBL377, 21FBU514, 21FDB653, 21FMA141, 21GBD005, 21GBM457, 21GDB275, 21GMB502, 21GMD986, 21GMF673, 21HBJ571, 21HBM290, 21HBN337, 21HBP277, 21HMF024, 21IBQ174, 21IBV915, 21IBX390 and 135 more |
| Model numbers | DYNJ67349, DYNJSCL100, DYNJSCL300 |
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRAM DYNJ28082D DYNJ28082F CARDIAC CATH DYNJ67349 CARDIAC CATH PACK DYNJ57874C CATH I PLUS-LF DYNJSCL100 CATH III PLUS-LF DYNJSCL300 CATH LAB ANGIOGRAPHY PACK DYNJ50779F CATH LAB PACK DYNJ41088B DYNJ48085 CATH LAB TRAY DYNJ37389N DYNJ37389O CATH PACK DYNJ62595A DYNJ69997 EP DRAPE PACK-LF DYNJ47645B HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918A INTERVENTIONAL PACK DYNJ56666C INTERVENTIONAL RAD PACK DYNJ44100L INTERVENTIONAL RADIOLOGY PACK DYNJ43664 INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AF OR HYBRID-MRMC DYNJ907758A VMA TRAY DYNJ62376A
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-2592-2026. 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.