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RecallWatchMedical Device Safety
Class IIOngoingZ-2587-2026

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

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. 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 PACKDYNJ30150F
    UDI-DI 10193489434040
    140 affected lots
    21CDC41121EDA76821EDC10721HDA93721HDC81521IDC20421KDA78022ADA317
    +132 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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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