Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ... recall (Medline Industries, LP)
Medical deviceClass IIOngoing
Summary: Medline Industries, LP is recalling 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 . Reason: Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
What is being recalled
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 PACK DYNJ51127B
Why
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin, Wyoming)
How to tell if yours is affected
DYNJ30565C UDI-DI 10889942165704 Lots 21CDA555 21DDA970 DYNJ32555B UDI-DI 10884389648216 Lot 21AMA053 DYNJ0774765U UDI-DI 10193489634594 Lot 21FLA468 DYNJ46153A UDI-DI 10889942185863 Lots 20XBH471 21BBC325 DYNJ33638K UDI-DI 10193489343281 Lot 21HLA726 DYNJ35110D UDI-DI 10193489329940 Lot 21IMC537 DYNJ44293D UDI-DI 10193489833416 Lots 21CBE250 21CBX084 21FBB546 21HBD075 21KBN509 22ABV463 22BBX022 22DBJ641 22HBB710 22HBT960 22IBD236 22OBF392 DYNJ0854485T UDI-DI 10193489864199 Lots 21FBC416 21GBL506 21IBO920 21JBS587 DYNJ35916J UDI-DI 10193489838404 Lots 21CBF463 21DBP668 21DBR247 DYNJ57760B UDI-DI 10193489342581 Lots 21CME104 21EME408 21FMD506 21GMG028 21JMF774 21KMH487 DYNJ0842873J UDI-DI 10193489448917 Lots 21ADA204 21CDB566 21EDB709 21GDC532 21HDC041 21JDB401 21JDC566 21LDA726 22BDA893 22CDC138 22EDA075 22FDC040 22HDB149 22JDA080 DYNJ51126A UDI-DI 10193489854886 Lots 21DDA694 21EDB249 21GDD164 21IDA472 21KDA815 DYNJ62858B UDI-DI 10193489891263 Lots 21FMF601 21HMF637 21HMG835 21JMF531 DYNJ51127B UDI-DI 10193489854893 Lot 22FBV791
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2591-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 27, 2026 |
| Reported | July 1, 2026 |
| Company | Medline Industries, LP |
| Company location | Northfield, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 113,843 kits |
More recalls from Medline Industries, LP · all medical device recalls · recalls from February 2026