DeRoyal CARDIAC LINEN PACK Recall: Safety Hazard

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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 CARDIAC LINEN PACK products that may have a safety hazard. This recall affects consumers who own these particular lot numbers with expiration dates from November 2023 through May 2024.

Why it’s dangerous

The recall record does not specify what the hazard is or why the product is dangerous. Without this information, it's impossible to explain the hazard mechanism.

Who’s affected

Owners of DeRoyal CARDIAC LINEN PACK with lot numbers 56336988 (expires 11/1/2023), 57188770 (expires 8/1/2024), 57393440 (expires 5/1/2024), or 57644325 (expires 7/1/2024) are affected. These products are typically used in home settings.

How to tell if you have this one

Check your CARDIAC LINEN PACK for the lot number on the packaging. Affected lots include 56336988 (expires 11/1/2023), 57188770 (expires 8/1/2024), 57393440 (expires 5/1/2024), and 57644325 (expires 7/1/2024).

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 the CARDIAC LINEN PACK packaging to determine if it is affected.

✎ GovInfoNow

Questions people ask

What is the hazard with these products?

The recall record does not specify what the hazard is.

How do I know if my product is affected?

Check the lot number on the packaging. Affected lots include 56336988 (expires 11/1/2023), 57188770 (expires 8/1/2024), 57393440 (expires 5/1/2024), and 57644325 (expires 7/1/2024).

What should I do if my product is affected?

The recall record does not specify a remedy for affected products.

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-0691-2023 — DeRoyal DeRoyal

Hello,

I own a DeRoyal that is covered by recall Z-0691-2023 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-0691-2023 (November 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0691-2023 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 CARDIAC LINEN PACK, REF 89-10543.02

Recall notice