DRG International, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0921-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

Product Classification:

Class II

Date Initiated: October 7, 2024

Date Posted: January 22, 2025

Recall Number: Z-0921-2025

Event ID: 95785

Reason for Recall:

The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which causes a delay in results.

Status: Ongoing

Product Quantity: 10 units

Code Information:

UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1

Distribution Pattern:

Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.

Voluntary or Mandated:

Voluntary: Firm initiated