Z-2581-2026Class II
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-02-27 / Open, Classified / root cause: design
Medline Industries, LP began a recall of Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126 on . FDA classified it as Class II and gives the reason as "Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2581-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126
- Product code
- OEQ Angiography/Angioplasty Kit
- 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.
- Root cause tag
- design
- FDA root cause
- No Marketing Application
- Action
- This entry catalogues SKUs communicated through the same letter documented in RES 98601 which were inadvertently missed in the initial report to the FDA. Firm began notifying customers on February 27, 2026 via letters titled "URGENT MEDICAL DEVICE RECALL". Customers were instructed to immediately check stock for affected product and quarantine any affected units. Upon receipt of the customers' response form reporting the quantity of affected product on hand, the firm will provide over-labels to place on affected inventory. Labels contain instructions for staff to remove and discard the affected component prior to using the kit.
- Quantity in commerce
- 113,843 kits
- Distribution
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.
- Product codes and lots
- DYNJ21574J UDI-DI 10889942153497 Lots 21ALA586 21CLA398 21ELA408 21FLA144 21FLA788 21HLA420 21ILA431 DYNJ51126 UDI-DI 10889942122820 Lots 21ADA917
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2581-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2582-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2583-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2584-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2585-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2586-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2587-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2588-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2589-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2590-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2591-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2592-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2593-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2594-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2595-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2596-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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