FDA Medical devices recall ·
Convenience kits containing select SKUs of 10mL Polycarbonate Colored… recall
- Recall number
- Z-2592-2026
- Date
- (initiated February 27, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 113, 843 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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 TRAY DYNJ62376A
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
DYNJ47665D UDI-DI 10193489952827 Lots 21HBJ571 21JBD819 21LBA976 22BBP310 22CBW541 22CMH003 22DMD476 22EMA241 22FMF056 22HMC694 22HME818 22IMC158 22IMG796 22JMD311 22LMD944 22NBC196 23AMB219 DYNJ30565D UDI-DI 10193489905205 Lots 21FDB653 21GDB275 DYNJ0854485V UDI-DI 10195327096885 Lots 22CMB440 22EMF763 22HMA699 22HMG186 22IMD134 22LME930 23BMC883 23CMB807 23CMI020 DYNJ28082D UDI-DI 10193489268676 Lots 21ABN806 21BBP110 21DBL217 21EBS784 21FBU514 DYNJ28082F UDI-DI 10193489949452 Lots 21HBM290 21IBQ174 21KBO096 21KBO098 DYNJ67349 UDI-DI 10193489895728 Lots 23JMA721 24BMF147 DYNJ57874C UDI-DI 10193489976618 Lot 24ABM611 DYNJSCL100 UDI-DI 10884389625583 Lot 24ABM801 DYNJSCL300 UDI-DI 10884389625606 Lot 24ABM802 DYNJ50779F UDI-DI 10193489436068 Lots 21DME914 21EMF097 21GMB502 21JMA420 22BMA533 22BMB246 22DMA002 22DMD984 22DMI243 22EMG746 22GMB725 22HMH063 22IME310 22KMA626 23AME217 23BME137 23DMH595 23EMI849 23FMJ773 23JMB530 23LMH087 24BMF696 24CMJ355 24DMA986 DYNJ41088B UDI-DI 10889942632794 Lot 21ABG127 DYNJ48085 UDI-DI 10888277546035 Lot 24AMF987 DYNJ37389N UDI-DI 10193489306019 Lots 21ABN379 21CBU277 21DBP810 DYNJ37389O UDI-DI 10193489925302 Lots 21FBL377 21GBD005 21HBN337 21JBW141 21JBW142 21LBG627 22ABH544 22CBF313 22DBD511 22DBE512 22FBS027 DYNJ62595A UDI-DI 10193489364262 Lots 21ABH085 21ABI181 21ABV975 21BBO277 21CBU091 21EBA810 DYNJ69997 UDI-DI 10195327004743 Lots 22DBK793 22IBD718 22IBE297 22OBC253 DYNJ47645B UDI-DI 10193489952834 Lots 21GBM457 21IBV915 21KBF627 21LBA
Distribution
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: 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
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2592-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.