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RecallWatchMedical Device Safety
Class IIOngoingZ-2592-2026

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 DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRAM DYNJ28082D DYNJ28082F CARDIAC CATH DYNJ67349 CARDIAC CATH PACK DYNJ57874C CATH I PLUS-LF DYNJSCL100 CATH III PLUS-LF DYNJSCL300 CATH LAB ANGIOGRAPHY PACK DYNJ50779F CATH LAB PACK DYNJ41088B DYNJ48085 CATH LAB TRAY DYNJ37389N DYNJ37389O CATH PACK DYNJ62595A DYNJ69997 EP DRAPE PACK-LF DYNJ47645B HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918A INTERVENTIONAL PACK DYNJ56666C INTERVENTIONAL RAD PACK DYNJ44100L INTERVENTIONAL RADIOLOGY PACK DYNJ43664 INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AF OR HYBRID-MRMC DYNJ907758A VMA TRAYDYNJ62376A
    UDI-DI 10193489952827
    198 affected lots
    21HBJ57121JBD81921LBA97622BBP31022CBW54122CMH00322DMD47622EMA241
    +190 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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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