Convenience kits containing select SKUs of 10mL Polycarbonate Colored… — Class II medical device recall Z-2582-2026
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-2582-2026 |
|---|---|
| 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 | 10195327181000, 10195327185749, 10195327195489, 10195327202590, 10195327232887, 10195327265496, 10195327272890, 10195327291792, 10195327322984, 10195327335502, 10195327403430, 10195327410780, 10195327461317, 10195327467760, 10195327624903, 10198459152108 |
| Lot numbers | 22GBD778, 22GMH445, 22HDA577, 22HME111, 22IME517, 22JMF050, 22KBG072, 22LBM317, 22LMH296, 22LMI014, 23ABM307, 23ABR612, 23BMG740, 23CBG406, 23CBU167, 23DBT002, 23DMD313, 23EBS228, 23EMF238, 23EMI244, 23FMH270, 23GMF506, 23HME060, 23ILA143, 23IMA846, 23JLA076, 23JLA420, 23KLB055, 23LLA790, 24ALA692, 24BLA009, 24BLA835, 24CBG978, 24CLA859, 24CME277, 24ELA213, 24ELA684, 24FLA287, 24GLA266, 24HLA117 and 24 more |
| Model numbers | DYNJ0261554AL, DYNJ31103F |
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO CATH COMBINED PACK DYNJ43609S ANGIO PACK DYNJ67987D DYNJ80317A ANGIO SPECIAL PROCEDURE-LF DYNJ38412C ANGIOGRAM SET UP PACK DYNJ66260A ANGIOGRAPHY PACK DYNJ44293I ANGIOGRAPHY PACK-LF DYNJ0854485W CARDIAC CATH PACK DYNJ82709 CARDIAC CATH PACK-LF DYNJ0261554AL DYNJ31103F CATH LAB ANGIO TRAY DYNJ83506 CATH LAB PACK DYNJ66366C MSC-GREEN BAY ST VINCENT SAMPC0686 NEUROLOGICAL CATH PACK DYNJ63434B OR HYBRID-MRMC DYNJ907758B STEWARD OR ANGIO PACK GSS DYNJ80925B
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-2582-2026. 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.