DeRoyal Industries Inc recalls REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
DeRoyal recalls 400 Series Myocardial Probes with 18mm needle instead of 15mm. This incorrect size may cause injury during medical procedures. Affected units sold with specific lot numbers.
Lower-risk recall
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
What happened, in plain English
DeRoyal is recalling its 400 Series Myocardial Probes because they include an 18mm needle instead of the required 15mm needle. This incorrect size could lead to injury during medical procedures. The recall affects specific lot numbers sold with the product. Read more at govinfonow.com/recall/1292580-deroyal-myocardial-probe-recall-incorrect-needle-size-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/1292580-deroyal-myocardial-probe-recall-incorrect-needle-size-hazard · Published October 6, 2026 · Updated October 6, 2026 · FDA enforcement record: FDA #Z-3256-2026
Cite this page
“DeRoyal Myocardial Probe Recall: Incorrect Needle Size Hazard.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/1292580-deroyal-myocardial-probe-recall-incorrect-needle-size-hazard. Based on FDA recall #Z-3256-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3256-2026%22&limit=1).
Why it’s dangerous
The probe includes an 18mm needle instead of the 15mm needle that was intended. This incorrect size could cause injury during medical procedures, such as tissue damage or improper insertion.
Who’s affected
Medical professionals using the 400 Series Myocardial Probes with lot number 63426754 are most at risk. Patients receiving procedures with these probes may also be affected.
How to tell if you have this one
Check for the product name 'Myocardial Probe Non-Pyrogenic, 400 Series' with lot number 63426754. The recall covers specific units sold with this lot number.
- Brand
DeRoyal- Category
Medical device
What to do — step by step
Check Product Details
Verify the lot number on the probe to confirm if it matches 63426754.
Questions people ask
Why is this probe being recalled?
The probe includes an 18mm needle instead of the required 15mm needle, which could cause injury during medical procedures.
What should I do if I have this probe?
Check the lot number on the probe. If it matches 63426754, contact DeRoyal for further instructions.
Is there a risk of serious injury?
The recall indicates a potential injury risk, but the official notice does not specify if serious injury is possible.
Contact DeRoyal
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-3256-2026 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-3256-2026 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-3256-2026 (August 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3256-2026 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.