DeRoyal OPEN SHOULDER PROCEDURE PACK RF Recall: Safety Hazard

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Contact the company & request your remedy

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 its OPEN SHOULDER PROCEDURE PACK RF product with lot number 56391733 (expired 3/1/2024) because of a safety hazard. This recall affects users who have the specific lot number and may pose a risk if not addressed.

Why it’s dangerous

The recall record does not specify the hazard mechanism. Without details on the hazard, it's impossible to explain why the product is dangerous.

Who’s affected

Users who purchased the DeRoyal OPEN SHOULDER PROCEDURE PACK RF with lot number 56391733 (expired 3/1/2024) are affected. Individuals using this product for medical procedures may be at higher risk.

How to tell if you have this one

Check for the product name 'OPEN SHOULDER PROCEDURE PACK RF' and lot number 56391733, which expires March 1, 2024. This specific lot was recalled by DeRoyal Industries Inc.

Brand
DeRoyal
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify if your product has lot number 56391733 and expires March 1, 2024.

✎ GovInfoNow

Questions people ask

Is this product dangerous?

The recall record does not specify the hazard mechanism, so it's unknown if the product is dangerous.

How do I know if I have the recalled product?

Check for the product name 'OPEN SHOULDER PROCEDURE PACK RF' and lot number 56391733 (expired 3/1/2024).

What should I do if I have the recalled product?

The recall record does not specify a remedy, so no action steps are provided.

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-0574-2023 — DeRoyal DeRoyal

Hello,

I own a DeRoyal that is covered by recall Z-0574-2023 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-0574-2023 (November 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0574-2023 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 OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07

Recall notice