The Recall Desk
ModerateFDA (Devices)·Z-0577-2023·Announced 2022-12-21

GEO-MED PLASTIC HAND PACK RF Medical Device Recall

DeRoyal Industries Inc is recalling 102 kits of the GEO-MED PLASTIC HAND PACK RF. The reason for the recall is not publicly specified. The recall affects 23 US states and was voluntarily initiated by the manufacturer.

What this means for you

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: This is a Class II voluntary recall with no reported adverse events or specified hazard in the public documentation. Voluntary precautionary recalls without reported patient harm align with the Moderate severity category.

Plain-English summary

DeRoyal Industries Inc is recalling 102 kits of the GEO-MED PLASTIC HAND PACK RF (Reference 89-6667.10). The affected lot numbers are 57391655 and 57895706, both with an expiration date of June 1, 2023.

The reason for this Class II recall has not been publicly specified in the available documentation. The device was distributed across 23 US states including Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.

This recall was voluntarily initiated by the manufacturer. Healthcare facilities and distributors that received this product should contact DeRoyal Industries Inc for instructions regarding the affected kits.

The recalled product

Product
GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10
Manufacturer
DeRoyal Industries Inc

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 (2)

  • Lot Numbers: Lot 57391655 exp 6/1/2023
  • Lot 57895706 exp 6/1/2023

Distribution

Distribution scope not specified by the agency.