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RecallWatchMedical Device Safety
Class IIOngoingZ-2591-2026

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. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY PACK DYNJ44293D ANGIOGRAPHY PACK-LF DYNJ0854485T DYNJ35916J GENERAL ANGIO PACK DYNJ57760B GENERAL ENDO PACK-LF DYNJ0842873J JUDKINS PACK DYNJ51126A RADIOLOGY ANGIO MAJOR PACK DYNJ62858B TAVR JUDKINS PACKDYNJ51127B
    UDI-DI 10889942165704
    83 affected lots
    21CDA55521DDA970DYNJ32555B1088438964821621AMA053DYNJ0774765U1019348963459421FLA468
    +75 moreDYNJ46153A1088994218586320XBH47121BBC325DYNJ33638K1019348934328121HLA726DYNJ35110D1019348932994021IMC537DYNJ44293D1019348983341621CBE25021CBX08421FBB54621HBD07521KBN50922ABV46322BBX02222DBJ64122HBB71022HBT96022IBD23622OBF392DYNJ0854485T1019348986419921FBC41621GBL50621IBO92021JBS587DYNJ35916J1019348983840421CBF46321DBP66821DBR247DYNJ57760B1019348934258121CME10421EME40821FMD50621GMG02821JMF77421KMH487DYNJ0842873J1019348944891721ADA20421CDB56621EDB70921GDC53221HDC04121JDB40121JDC56621LDA72622BDA89322CDC13822EDA07522FDC04022HDB14922JDA080DYNJ51126A1019348985488621DDA69421EDB24921GDD16421IDA47221KDA815DYNJ62858B1019348989126321FMF60121HMF63721HMG83521JMF531DYNJ51127B1019348985489322FBV791

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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