HomeMedical Device recalls
Medium severity

Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model Number: DYNJ53369C;

SourceFDA Device Enforcement
CategoryMedical Device
SeverityMedium
Statusongoing
Recall dateFebruary 25, 2026
ReportedApril 29, 2026
Recalling firmMedline Industries, LP
Country / regionUnited States IL

Hazard

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Product description

Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model Number: DYNJ53369C; 7) ANGIO PACK, Model Number: DYNJ53591A; 8) ANGIOGRAPHIC PACK, Model Number: DYNJ57516; 9) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ58722A; 10) ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; 11) CEREBRAL ANGIOGRAM, Model Number: DYNJ67876; 12) CSU CATH MANIFOLD KIT, Model Number: VASC1170A

Affected products

Related recalls

3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS- · May 20, 2026QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp. · May 20, 2026Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: · May 20, 2026Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 · May 20, 2026BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER · May 20, 2026