CLASS II Device recall · Reported 9 May 2018 · FDA Enforcement Report
DeRoyal(R) Surgi Mate(R) Electrosurgical Pencil recalled
DeRoyal Industries is recalling DeRoyal(R) Surgi Mate(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord. The recall was initiated on 23 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1583-2018
- FDA event ID
- 79939
- Recalling firm
- DeRoyal Industries, Powell, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Apr 2018
- FDA classified
- 1 May 2018
- Reported
- 9 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 23 Apr 2018 | Recall initiated by company | |
| 1 May 2018 | Classified by FDA | +8 days |
| 9 May 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-sterile product was packaged inside a case that was labeled as sterile.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical
Where it was distributed
Honduras, Belgium, and The Netherlands
Questions about this recall
Why was it recalled?
Non-sterile product was packaged inside a case that was labeled as sterile.
Which lots are affected?
Lot Number 44210051
Where was it sold?
Honduras, Belgium, and The Netherlands
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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