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Medline Industries, LP: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK

Medical DevicesSource: FDA (device) · Date: 2026-07-01

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medline Industries, LP
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C POSTERIOR SPINE PACK-LF DYNJ0843339O UPPER EXTREMITY DYNJ61907A VISCERAL ANGIOGRAM PACK-LF DYNJ0429121L
Reason / hazard
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-02-27
Code info
DYNJ85743 UDI-DI 10195327542337 Lots 24ABP082 24BBA479 DYNJ81610C UDI-DI 10195327556938 Lot 24BBB405 DYNJ0843063L UDI-DI 10195327567071 Lots 23LDB992 24BDA641 24BDA782 24FDA795 24GDB014 24HDB074 DYNJ54755J UDI-DI 10195327549909 Lots 24ABJ741 24CBI600 24EBA488 24FBM084 24GBN355 24HBH571 DYNJ61383C UDI-DI 10195327593346 Lot 24CLA801 DYNJ0843339O UDI-DI 10195327567057 Lots 24CDB480 24DDA248 24GDB068 DYNJ61907A UDI-DI 10195327542450 Lot 24ABP069 DYNJ0429121L UDI-DI 10195327587697 Lot 24BMH315
Product quantity
113,843 kits
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
99062
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