Z-1583-2018Class II

DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF...

Name: Z-1583-2018 DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF...
Creator: DeRoyal Industries Inc
Published: 2018-04-23
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2018-04-23 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of 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 on 2018-04-23. FDA classified it as Class II and gives the reason as "Non-sterile product was packaged inside a case that was labeled as sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1583-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-23
Posted: 2018-05-01
Terminated: 2018-11-09
Recalling firm: DeRoyal Industries, Inc.
Product: 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
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Non-sterile product was packaged inside a case that was labeled as sterile.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DeRoyal sent an Urgent Recall Notice letter dated April 23, 2018 to affected customers. The letter identified the affected products, problems and actions to be taken. The recall notices requested destruction of the product at the consignee level. Distributors were asked to notify their consignees or to provide the list to DeRoyal for notification. For questions contact your DeRoyal Representative, customer service at 888-938-7828 or by email at [email protected]
Quantity in commerce: 1800 pencils
Distribution: Honduras, Belgium, and The Netherlands
Product codes and lots: Lot Number 44210051

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1583-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1583-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-01

Product code GEI

K940909Class IIElectrosurgical Monopolar Handswitching Pencil W/removable BladeDebusk Technology Corp. / cleared 1994-03-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)