Convenience kits containing select SKUs of 10mL Polycarbonate Colored… — Class II medical device recall Z-2587-2026
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-2587-2026 |
|---|---|
| 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 | 10193489345544, 10193489397369, 10193489397475, 10193489427264, 10193489434040, 10193489908961, 10193489964615, 10193489996371, 10195327219949, 10195327219987, 10195327286255, 10195327286484, 10195327286552, 10195327405847, 10195327406028, 10195327500177, 10195327536145, 10195327556884, 10889942186679 |
| Lot numbers | 21BLA577, 21CBF265, 21CDC411, 21DLA194, 21DLA397, 21EBI411, 21EDA768, 21EDC107, 21EDC223, 21FBF870, 21FDB611, 21HBC497, 21HBK984, 21HBO573, 21HBT672, 21HDA937, 21HDB435, 21HDC815, 21IDB916, 21IDC204, 21JBD205, 21KDA780, 21KDC093, 21LBC602, 21LBQ932, 22ADA317, 22ADC159, 22BBB708, 22BBQ673, 22BDA066, 22BDA178, 22CDA470, 22CMH568, 22DBP992, 22DBQ776, 22DDA738, 22EDA069, 22EDB043, 22EDB214, 22EDB876 and 82 more |
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F DYNJ0101292G HYBRID PACK DYNJ65925A LAMINECTOMY DYNJ905156L DYNJ905156M DYNJ905156N DYNJ905156O DYNJ905156P MAJOR EXTREMITY DYNJ905159F DYNJ905159I DYNJ905159J DYNJ905159K NEURO CERVICAL PACK DYNJ0101287J DYNJ0101287K NEURO SPINE PACK DYNJ81612C POSTERIOR SPINE PACK-LF DYNJ0843339L DYNJ0843339M DYNJ0843339N SPINE PACK DYNJ30150F
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-2587-2026. 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.