DRG International recalls Hybrid-XL insulin model HYE-5361 due to calibration failures causing delayed results. Affected units have specific UDI and lot numbers.
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.
“DRG Hybrid-XL Insulin Recall: Calibration Failure Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53785-drg-hybrid-xl-insulin-recall-calibration-failure-risk. Based on FDA recall #Z-0921-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0921-2025%22&limit=1).
The FDA announced on Oct. 7, 2024, that DRG International, Inc. is recalling DRG:HYBRiD-XL Insulin (Model HYE-5361) due to potential calibration failures and out-of-specification controls. The agency issued recall number Z-0921-2025 for the Class II device.
How to tell if you have it
Brand: DRG
Product: DRG:HYBRiD-XL Insulin
Model/Catalog Number: HYE-5361
UPC: 04048474053616
Lot Number: 429K084-1
UDI: (01)04048474053616(17)20251130(10)429K084-1
The hazard
According to the FDA, users may encounter a failure message during re-calibration of the Hybrid.XL instrument or find controls out of specification. This defect causes a delay in results for the assay.
Context
GovInfoNow's records show DRG International, Inc. has issued five other recalls since Oct. 18, 2021. Other recent recalls include the T4 Total ELISA Kit (June 4, 2025), the DRG 17-OH Progesterone Kit (Sept. 13, 2024), and the DRG Salivary Testosterone ELISA SLV-3013 (July 5, 2024). Other recent recalls of similar products include the Medtronic MiniMed 670G Insulin Pump recall (July 13, 2026), the Medtronic MiniMed 780G Insulin Pump recall (July 13, 2026), and the Medtronic MiniMed 630G Insulin Pump recall (Feb. 13, 2026).
How to tell if you have this one
Check for the model number HYE-5361 and lot number 429K084-1 on the device. The unique device identifier (UDI) starts with (01)04048474053616(17)20251130(10)429K084-1.
Verify if the device shows failure messages during re-calibration or has controls out of specification.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 4 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0921-2025 (October 7, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0921-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.