The Recall Desk
ModerateFDA (Devices)·Z-0583-2023·Announced 2022-12-21

Medical device breast tray recalled by DeRoyal Industries Inc

DeRoyal Industries voluntarily recalled 162 breast tray kits (REF 89-7033.07). The specific reason for the recall was not publicly disclosed.

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 voluntary, firm-initiated recall of an FDA Class II medical device with no publicly stated reason, no reported illnesses, and no reported injuries. It aligns with the rubric category of voluntary precautionary recalls, classified as Moderate severity.

Plain-English summary

DeRoyal Industries Inc. initiated a voluntary recall of its breast tray (REF 89-7033.07), affecting 162 kits. The recall was initiated on November 3, 2022, and was classified as FDA Class II.

The specific reason for this recall has not been disclosed in publicly available documents. The affected lot numbers are Lot 56390335 and Lot 57001021, both with an expiration date of January 1, 2024.

The product was distributed across 23 U.S. 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. The recall remains ongoing as of the public report date.

The recalled product

Product
DeRoyal BREAST TRAY, REF 89-7033.07
Manufacturer
DeRoyal Industries Inc
Category
Medical Device

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 56390335 exp 1/1/2024
  • Lot 57001021 exp 1/1/2024

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category