DeRoyal SURGI MATE Electrosurgical Pencils Recalled for Sterility Labeling Error
DeRoyal Industries is recalling 1,800 non-sterile electrosurgical pencils that were incorrectly labeled as sterile. The affected units were distributed to Honduras, Belgium, and The Netherlands.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling error without reporting any specific illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
DeRoyal Industries Inc is recalling 1,800 units of the DeRoyal SURGI MATE Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502. The recall is due to a packaging error where non-sterile products were packaged inside a case that was labeled as sterile.
The affected units are identified by Lot Number 44210051. These products were distributed to Honduras, Belgium, and The Netherlands. The product is intended for general surgical use.
Healthcare facilities and consumers should stop using the affected electrosurgical pencils and contact DeRoyal Industries Inc for instructions on how to return the product or obtain a replacement.
The recalled product
- 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
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 1,800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number 44210051
Distribution
Distribution scope not specified by the agency.
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