Recall Z-1876-2026

Medline Industries, LP · initiated February 27, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK DYNJ32555C, DYNJ66631 ANGIO TRAY DYNJ46153B ANGIOGRAPHY PACK DYNJ26855F ANGIOGRAPHY PACK-M-LF DYNJ24530I ANGIOGRAPHY TRAY-LF DYNJ0220880V, DYNJ30077D CATH LAB ANGIO PACK-LF DYNJ0545064X CATH LAB PACK DYNJ39057C FEMORAL ANGIOGRAPY SET UP DYNJ61015B RAD-ANGIO PACK DYNJ47710C SURGERY ANGIO PACK-LF PHS677784013A

Codes / lots: DYNJ51126 UDI-DI 10889942122820 (EA) 40889942122821 (CS) LOT 20ADA585 DYNJ32555C UDI-DI 10193489859485 (EA) 40193489859486 (CS) LOTS 21HMF699 21IMF813 21JMA855 21KMD605 22DMB423 22FMD574 22HMB608 22LMA169 23BMA114 23EMB817 23EMG153 23KMB692 23KMH359 23LMH085 24AMC563 24CMD587 24DMD256 24DMG305 24FMD717 24IMI650 24JMC830 DYNJ66631 UDI-DI 10193489368321 (EA) 40193489368322 (CS) LOTS 22BBB494 22BBB497 DYNJ46153B UDI-DI 10193489853643 (EA) 40193489853644 (CS) LOTS 23EBM225 23FBC884 23HBP278 23IBV999 23KBC319 23LBK125 24CBF100 24DBE952 24FBP262 24GBN960 24HBO921 24IBO007 24IBU941 24JBK669 24LBK644 DYNJ26855F UDI-DI 10888277012042 (EA) 40888277012043 (CS) LOTS 20CBI049 20EBB600 20FBK900 20GBD331 20GBL795 20IBC788 20JBM786 20KBF148 21BBK244 21EBR327 21HBB849 21IBQ809 21OBA396 DYNJ24530I UDI- DI 10193489674910 (EA) 40193489674911 (CS) LOT 24ABU775 DYNJ0220880V UDI-DI 10889942054688 (EA) 40889942054689 (CS) LOTS 23HLA505 23HLB257 23JLA021 23JLA059 23KLA121 23KLA231 23KLA582 23LLA817 24ELA405 24ELA796 24HLA596 25AMI609 25BMH660 25CMA797 25DMF893 DYNJ30077D UDI-DI 10889942138630 (EA) 40889942138631 (CS) LOTS 23FBQ479 23LBL707 24CBC495 24EBQ346 24GBK895 24HBD023 24HBP290 24JBJ112…

Reason for recall

Unapproved design changes to the products outside of the 510(k) clearance.

FDA-determined cause: Component change control

Action taken

On February 27, 2026, the firm began notifying customers via email and first-class mail. Customers were instructed to request over-labels to place on affected kits containing recalled syringes instructing them to remove the recalled component and replace with product from their supply.

Details

Recall number
Z-1876-2026
Initiated
February 27, 2026
Posted by FDA
April 17, 2026
Product code
OEQ – Angiography/Angioplasty Kit
Quantity
270,311 total
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Recalling firm
Medline Industries, LP, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1877-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1878-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1879-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1880-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1881-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1882-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1883-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1884-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1885-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1886-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1887-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1888-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1889-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1890-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1891-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified
Z-1892-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. 02/27/2026Open, Classified