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RecallWatchMedical Device Safety
Class IIOngoingZ-2586-2026

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

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. 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 PACKDYNJ36338B
    UDI-DI 10193489250558
    176 affected lots
    21BMA604DYNJ0842793G1019532729366622LDA18323EDB04923HDC04223JDA98824DDA005
    +168 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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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