FDA-Device2026-07-01Class IIMISBRANDING
Medline surgical convenience kits with syringes recalled for unapproved design changes
FALSE CLAIMSNationwide distribution
Medline surgical kits recalled for unapproved design changes
Medline Industries identified that certain surgical convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The kits were distributed nationwide and include craniotomy, spine, laminectomy, and neuro packs used in operating rooms.
- Check if your facility received any of the affected kit models listed in the recall notice
- Do not use affected kits; contact your Medline representative for instructions on return or replacement
- Review lot numbers and UDI codes on packaging to identify affected products
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.
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. CRANIOTOMY PACK-LF DYNJ0101292F DYNJ0101292G HYBRID PACK DYNJ65925A LAMINECTOMY DYNJ905156L DYNJ905156M DYNJ905156N DYNJ905156O DYNJ905156P MAJOR EXTREMITY DYNJ905159F DYNJ905159I DYNJ905159J DYNJ905159K NEURO CERVICAL PACK DYNJ0101287J DYNJ0101287K NEURO SPINE PACK DYNJ81612C POSTERIOR SPINE PACK-LF DYNJ0843339L DYNJ0843339M DYNJ0843339N SPINE PACK DYNJ30150F
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2587-2026More Medline Industries, LP recalls
- FDA-Device2026-07-01Medline surgical convenience kits recalled for unapproved syringe design changes
- FDA-Device2026-07-01Convenience 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 DYNJ62
- FDA-Device2026-07-01Medline medical convenience kits with syringes recalled for unapproved design changes
- FDA-Device2026-07-01Convenience 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 DYNJ
- FDA-Device2026-07-01Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: CV ANESTHESIA - ROOM SET UP
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