The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0663-2023·Announced 2022-12-21

Medical Device Recall: DeRoyal Breast Augmentation Pack Class II

DeRoyal Industries initiated a voluntary Class II recall of 70 kits of its Breast Augmentation Pack distributed across 23 US states. The specific reason for the recall is not stated in available FDA materials.

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 Class II recall initiated by the manufacturer. No illnesses, injuries, or deaths are reported in available FDA materials. Voluntary precautionary recalls without reported harm are classified as Moderate severity.

Plain-English summary

DeRoyal Industries Inc is voluntarily recalling 70 kits of its Breast Augmentation Pack (REF 89-9618.05) under FDA Class II classification. The recall was initiated on November 3, 2022, and remains ongoing.

The specific reason for this recall is not provided in available FDA documentation. The affected product was distributed to healthcare facilities in 23 US 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.

The recalled lot numbers are: Lot 55968916 (expiration 7/1/2023), Lot 56620786 (expiration 7/1/2023), and Lot 56780667 (expiration 7/1/2023). Healthcare providers and individuals should contact DeRoyal Industries Inc or the FDA for further information and instructions regarding the recalled product.

The recalled product

Product
DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical / Breast Augmentation
Affected units
70

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 (3)

  • Lot Numbers: Lot 55968916 exp 7/1/2023
  • Lot 56620786 exp7/1/2023
  • Lot 56780667 exp 7/1/2023

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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