FDA-Device2026-07-01Class IIMISBRANDING
Medline angiogram and Judkins syringe kits recalled for unapproved design changes
Medline syringe kits recalled for unapproved design changes
Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The affected kits include Angiogram Pack-LF and Judkins Pack models distributed nationwide.
- Check if you have the affected lots: DYNJ21574J (lots 21ALA586, 21CLA398, 21ELA408, 21FLA144, 21FLA788, 21HLA420, 21ILA431) or DYNJ51126 (lot 21ADA917).
- Contact Medline Industries or your supplier for instructions on how to proceed with affected kits.
- Do not use kits with the affected lot numbers until you receive guidance from Medline.
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.
Who it affects
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
113,843 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2581-2026More Medline recalls
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- FDA-Device2026-07-29Medline surgical convenience kits recalled for quality issues in anesthetic component
- FDA-Device2026-07-29Medline NEURO PACK medical kits recalled for Bacillus contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
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