DeRoyal Industries Inc: Medical Device Recall in 2018 - (Recall #: Z-1583-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 23, 2018

Date Posted: May 9, 2018

Recall Number: Z-1583-2018

Event ID: 79939

Reason for Recall:

Non-sterile product was packaged inside a case that was labeled as sterile.

Status: Terminated

Product Quantity: 1800 pencils

Code Information:

Lot Number 44210051

Distribution Pattern:

Honduras, Belgium, and The Netherlands

Voluntary or Mandated:

Voluntary: Firm initiated