DRG Hybrid-XL Insulin Recall: Calibration Failure Risk

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Contact the company & request your remedy

Recalling firmDRG International, Inc.841 Mountain Ave · Springfield, NJ 07081-3437

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

DRG International is recalling Hybrid-XL insulin model HYE-...

Why it’s dangerous

The device may show failure messages during re-calibration or have controls out of specification, causing delays in test results. This could lead to inaccurate insulin measurements if the device is not functioning properly.

Who’s affected

Users of the Hybrid-XL insulin device with model HYE-5361 and lot number 429K084-1 are affected. Healthcare professionals using this device for insulin testing are most at risk.

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.

Brand
DRG
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Status
Verify if the device shows failure messages during re-calibration or has controls out of specification.

✎ GovInfoNow

Questions people ask

What is the model number for the recalled insulin device?

The model number is HYE-5361.

What lot number is affected?

The lot number is 429K084-1.

How can I tell if my device is recalled?

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.

Take action

Contact DRG

We’ve drafted a message you can send DRG to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0921-2025 — DRG DRG

Hello,

I own a DRG that is covered by recall Z-0921-2025 from DRG.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

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.

DRG International, Inc. recalls DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

Lower-risk recall