DeRoyal SURGI MATE Electrosurgical Pencil: Non-sterile Packaging Risk
DeRoyal recalls SURGI MATE electrosurgical pencils with non-sterile packaging. This could lead to infection during surgery if used without proper sterilization.
Lower-risk recall
Non-sterile product was packaged inside a case that was labeled as sterile.
Contact the company
What happened, in plain English
DeRoyal is recalling electrosurgical pencils that were packaged as sterile but were actually non-sterile. This poses a risk of infection during surgery if the product is not properly sterilized before use. Read more at govinfonow.com/recall/71352-deroyal-surgi-mate-electrosurgical-pencil-non-sterile-packaging-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/71352-deroyal-surgi-mate-electrosurgical-pencil-non-sterile-packaging-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-1583-2018
Cite this page
“DeRoyal SURGI MATE Electrosurgical Pencil: Non-sterile Packaging Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/71352-deroyal-surgi-mate-electrosurgical-pencil-non-sterile-packaging-risk. Based on FDA recall #Z-1583-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1583-2018%22&limit=1).
Why it’s dangerous
The product was labeled as sterile but was packaged with non-sterile materials. If used without proper sterilization, this could lead to infection during surgery.
Who’s affected
Surgical teams using the DeRoyal SURGI MATE electrosurgical pencils with the specific model and lot number 44210051 are affected. The risk is highest for procedures requiring sterile instruments.
How to tell if you have this one
Check for the model number REF 88-001502 and lot number 44210051 on the product. The product is used in general surgical settings.
- Brand
DeRoyal- Category
Medical device
What to do — step by step
Check Product Details
Look for the model number REF 88-001502 and lot number 44210051 on the product.
How this recall unfolded
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1583-2018 (April 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1583-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.