Medline Industries, LP: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D

Hazard

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

Details from the source

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. Quantity: 270,311 total Lot/code info: DYNJ909398A UDI-DI 10195327338190 (EA) 40195327338191 (CS) LOTS 24GMH510 24HMG886 DYNJ908706D UDI-DI 10198459017773 (EA) 40198459017774 (CS) LOTS 24HMA783 24HMG308 24KMC651 24KMJ274 24LME931 25AME217 25BMI653 ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.*** DYNJ909398A lots 23EMF078 23HME512 23HMI269 23JMB528 23KME175 24EMC327

UPC codes

10195327338190, 40195327338191, 10198459017773, 40198459017774

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.