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RecallWatchMedical Device Safety
Class IIOngoingZ-2583-2026

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

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. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS PACK DYNJ905160J DYNJ905160K DYNJ905160M MINIMALLY INVASIVE PACK-LF DYNJ0843063K PERCUTANEOUS TRAY DYNJ80196 ROBOTIC PACK DYNJ908706DYNJ908706B
    UDI-DI 10193489395464
    108 affected lots
    21HBD98621HBO57021JBK10321LBC61022BBV02622CME90222GMG562DYNJ905153K
    +100 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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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