DeRoyal KIT EXTREMITY PACK recall: Safety hazard in specific lots

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

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

DeRoyal is recalling specific lots of KIT EXTREMITY PACK products due to safety concerns. Affected units have lot numbers 56390950 (expires 6/1/2026), 56837871 (expires 9/1/2026), or 5718781 (expires 10/1/2026). The recall is for safety reasons, but the exact hazard and remedy are not specified in the record.

Why it’s dangerous

The recall mentions safety concerns but does not specify the hazard mechanism. Without details on the hazard, it's impossible to determine why the product is dangerous.

Who’s affected

Owners of DeRoyal KIT EXTREMITY PACK with lot numbers 56390950, 56837871, or 5718781 are affected. Those who use the product for medical or athletic purposes may be at higher risk.

How to tell if you have this one

Check the lot number on your DeRoyal KIT EXTREMITY PACK. Affected units have lot numbers 56390950 (expires 6/1/2026), 56837871 (expires 9/1/2026), or 5718781 (expires 10/1/2026).

Brand
DeRoyal
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for the lot number on your DeRoyal KIT EXTREMITY PACK to see if it matches 56390950, 56837871, or 5718781.

✎ GovInfoNow

Questions people ask

What is the hazard with this product?

The recall record does not specify the hazard mechanism.

How do I know if my product is affected?

Check the lot number on your DeRoyal KIT EXTREMITY PACK. Affected units have lot numbers 56390950 (expires 6/1/2026), 56837871 (expires 9/1/2026), or 5718781 (expires 10/1/2026).

What should I do if my product is affected?

The recall record does not specify a remedy. 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-0628-2023 — DeRoyal DeRoyal

Hello,

I own a DeRoyal that is covered by recall Z-0628-2023 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-0628-2023 (November 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0628-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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 KIT EXTREMITY PACK, REF 89-8869.09

Recall notice