The Recall Desk
Agency classClass IIOur severity: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.

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 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
Affected units
162

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

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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