Convenience kits containing select SKUs of 10mL Polycarbonate Colored… — Class II medical device recall Z-2586-2026
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-2586-2026 |
|---|---|
| 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 | 10193489234886, 10193489250558, 10193489294071, 10193489388473, 10193489434033, 10193489444605, 10193489481006, 10193489567342, 10193489762129, 10193489777550, 10193489832082, 10193489872040, 10193489911558, 10193489925258, 10193489947113, 10195327054533, 10195327058104, 10195327170998, 10195327211806, 10195327260910, 10195327286491, 10195327293666, 10195327445072, 10195327470852, 10195327567064 and 1 more |
| Lot numbers | 21ABE325, 21ADB535, 21ALA184, 21BBQ398, 21BBR321, 21BMA293, 21BMA604, 21BMD592, 21CBH476, 21CBL981, 21CBO123, 21CDA247, 21CDC104, 21CMB071, 21DBI016, 21DBM014, 21DBV407, 21DMD790, 21EDA767, 21FBN698, 21FDC074, 21GBC948, 21GBP926, 21GDC130, 21HBD207, 21HBH690, 21HBI572, 21HBK163, 21HDA996, 21HDB833, 21HDC829, 21IBN513, 21JBN408, 21JBZ479, 21KBE479, 21KDA985, 21LBB983, 21LBL194, 21LDA070, 21LDA977 and 111 more |
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAPHY PACK-LF DYNJ0854485S DEEP BRAIN STIMULATION PACK DYNJ0842793G NEURO ACCESSORY PACK DYNJ55385A NEURO ANGIO PACK DYNJ51697B DYNJ56509G DYNJ56509I DYNJ68063 DYNJ68845 DYNJ68845A DYNJ68845B NEURO CERVICAL PACK DYNJ0101287I DYNJ0101287L NEURO PACK DYNJ82103 DYNJ82103A NEURO TRAY DYNJ67075 DYNJ67075A DYNJ67075B NEURO VASCULAR PACK DYNJ62960B NEURO VP SHUNT PACK-LF DYNJ0843121J DYNJ0843121K NEUROLOGICAL CATH PACK DYNJ63434A DYNJ63434C NEURORADIOLOGY PK DYNJ40420D RADIOLOGY ANGIO MAJOR PACK-LF DYNJ62858A RADIOLOGY NEURO DRAPE PAC DYNJ61449 RRMC ANGIO PACK DYNJ36338B
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-2586-2026. 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.