CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
DRG:HYBRiD-XL Insulin recalled by DRG International
DRG International is recalling DRG:HYBRiD-XL Insulin, distributed nationwide in the US. The recall was initiated on 7 Oct 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0921-2025
- FDA event ID
- 95785
- Recalling firm
- DRG International, Springfield, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Oct 2024
- FDA classified
- 15 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 7 Oct 2024 | Recall initiated by company | |
| 15 Jan 2025 | Classified by FDA | +100 days |
| 22 Jan 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Where it was distributed
Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1
Where was it sold?
Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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