The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0668-2023·Announced 2022-12-21

DeRoyal Facial Pack Medical Device Under Voluntary FDA Recall

DeRoyal Industries has voluntarily recalled 35 kits of DeRoyal FACIAL PACK PGYBK medical devices. The FDA classified the recall as Class II, and it remains ongoing.

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: This is an FDA Class II medical device recall initiated voluntarily by the manufacturer with no reported illnesses or injuries. It fits the rubric category of a voluntary precautionary recall.

Plain-English summary

DeRoyal Industries Inc is recalling 35 kits of DeRoyal FACIAL PACK PGYBK medical devices (Reference 89-10007.03). The recall includes two affected lots: Lot 55968449 with expiration date January 1, 2024, and Lot 56619751 with expiration date April 1, 2024.

The manufacturer initiated this recall voluntarily on November 3, 2022. The FDA classified it as Class II. The specific reason for the recall has not been disclosed in publicly available records.

The affected products were distributed to healthcare facilities in 23 states: 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.

Healthcare organizations that received these devices should contact DeRoyal Industries Inc for recall instructions. This recall remains ongoing.

The recalled product

Product
DeRoyal FACIAL PACK PGYBK, REF 89-10007.03
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Facial Care Device
Hazard
Affected units
35

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 55968449 exp 1/1/2024
  • Lot 56619751 exp 4/1/2024

Distribution

Distributed in 23 states:

Part of a larger recall action

This product is one of 156 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 156 products in this recall →

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