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RecallWatchMedical Device Safety
Class IIOngoingZ-2593-2026

Medline Industries, LP recalls Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ABDO…

Medline Industries, LPNorthfield, IL, United StatesReported Jul 1, 2026 · 17 days ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ABDOMINAL VASCULAR-LF DYNJ905291B DYNJ905291C ARTERIOGRAM DYNJ28082G CVICU HEART BAG DYKM2130A ENDOVASCULAR PACK DYNJ0678934J EP PACK DYNJ23456J GENERAL ENDO PACK-LF DYNJ0842873K HYBRID PACK DYNJ65925B DYNJ65925C NON VASCULAR PACK DYNJ68037 PACEMAKER DYNJ901681D PACEMAKER PACK DYNJ51853C DYNJ51853D DYNJ60606A PACER PACK DYNJ40952A RADIOLOGY VASCULAR ACCESS TRAY DYNJVB1303A SM- INTERVENTIONAL DRAPE PK-LF DYNJ0780143K VASCULAR ACCESS PACK-LF DYNJ0101291D VASCULAR DSC DYNJ69172 DYNJ69172B VASCULAR HYBRID DYNJ57543F DYNJ57543I DYNJ57543J VASCULAR PACKDYNJ61702A
    UDI-DI 10193489950373
    145 affected lots
    21GBO40521JBX73421LBO216DYNJ905291C1019532706254522BBB43422CBT55322CBT556
    +137 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

What the firm is doing

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.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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