DeRoyal MYELOGRAM PACK Recall: Risk of Fire in Normal Use

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Recalling firmDeRoyal Industries Inc200 Debusk Ln, N/A · Powell, TN 37849-4703

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✎ GovInfoNow plain-language explainer

What happened, in plain English

DeRoyal is recalling specific MYELOGRAM PACK products with lot numbers 55612944, 56615881, 56279557, 57185350, and 57591593. These packs could overheat and cause fire during normal use, so affected owners should stop using them immediately.

Why it’s dangerous

The packs can overheat during normal use, potentially leading to fire. This risk occurs even when the product is used as intended without any modifications.

Who’s affected

Owners of DeRoyal MYELOGRAM PACK with the listed lot numbers are affected. Anyone using these packs for medical purposes is at highest risk due to fire hazards.

How to tell if you have this one

Check the lot number on your DeRoyal MYELOGRAM PACK. The affected lots are 55612944 (expires 3/1/2026), 56615881 (expires 7/1/2026), 56279557 (expires 5/1/2026), 57185350 (expires 7/1/2026), and 57591593 (expires 1/1/2025).

Brand
DeRoyal
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using It Now
Immediately stop using the DeRoyal MYELOGRAM PACK with the listed lot numbers as they pose a fire risk.

✎ GovInfoNow

Questions people ask

What lot numbers are affected by this recall?

Lot numbers 55612944 (expires 3/1/2026), 56615881 (expires 7/1/2026), 56279557 (expires 5/1/2026), 57185350 (expires 7/1/2026), and 57591593 (expires 1/1/2025).

How can I check if my product is affected?

Check the lot number on your DeRoyal MYELOGRAM PACK. The affected lots are listed in the recall notice.

What should I do if I have the affected product?

Immediately stop using the product and contact DeRoyal for further instructions.

Take action

Contact DeRoyal

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

✉️ Open in email

Subject: Recall Z-0647-2023 — DeRoyal DeRoyal

Hello,

I own a DeRoyal that is covered by recall Z-0647-2023 from DeRoyal.

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-0647-2023 (November 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0647-2023 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.

DeRoyal Industries Inc recalls DeRoyal MYELOGRAM PACK, REF 89-9304.05

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