FDA recall Z-1883-2026

Product

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP PACK DYNJ80700 CORONARY ANGIOGRAPHY PACK (N) DYNJ42136B CSTM ANGIO KIT - S VASC1109 CV PACK DYNJ46301C DR F PACK DYNJ41253B ENSEMBLE HEMORROIDES DYNJ56311A G TAVR PACK DYNJ61006 IR MINOR PACK DYNJ44139C MAJOR PLUS PACK DYNJ905160N MAXIMUM BARRIER BUNDLE PACK DYNJ35216C PCI PACK TBRHSC-LF DYNJ41941D PERC PACK-LF DYNJ0774759P PERIPHERAL ANGIOGRAPHY PK DYNJ42094B PROCEDURE PACK DYNJ55063B PTCA PACK DYNJ55359B ROBOTIC PACK DYNJ908706C SPECIAL PROCEDURES TRAY DYNJ41174A SYRINGE WIRE KIT SANFORD SAMPC0644 WPH EP PACK DYNJ62745 X-RAY PACK DYNJ44295G

Reason for recall

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

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.

Key facts

Status

Ongoing

Initiation date

2026-02-27

Report date

2026-04-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1883-2026