The Recall Desk
ModerateFDA (Devices)·Z-0660-2023·Announced 2022-12-21

Medical Device Kit Recall — DeRoyal Abdominoplasty with Lipo Pack

DeRoyal Industries is recalling 438 abdominoplasty kits distributed across 23 US states. The reason for the recall is not disclosed in available FDA documentation.

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: FDA Class II classification with a voluntary manufacturer-initiated recall, no reported illnesses or injuries, and undisclosed hazard reason. This meets the profile of a precautionary recall without confirmed incident reports.

Plain-English summary

DeRoyal Industries Inc is recalling its ABDOMINOPLASTY W/LIPO PACK, REF 89-9557.03, a medical device kit used in surgical procedures. Approximately 438 kits are affected by this recall.

The affected kits were distributed to healthcare facilities across 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. Specific affected lot numbers include 55862118 (expires 6/1/2023), 56394942 (expires 6/1/2023), 57004352 (expires 9/1/2023), and 57686883 (expires 10/1/2023).

The FDA classified this recall as Class II. The manufacturer voluntarily initiated the recall on November 3, 2022. The FDA documentation does not specify the reason for the recall, and no illnesses or injuries have been reported.

Healthcare facilities that obtained these kits should verify their inventory against the affected lot numbers and contact DeRoyal Industries or the FDA for further guidance.

The recalled product

Product
DeRoyal ABDOMINOPLASTY W/LIPO PACK, REF 89-9557.03
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Kit

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 (4)

  • Lot Numbers: Lot 55862118 exp 6/1/2023
  • Lot 56394942 exp 6/1/2023
  • Lot 57004352 exp 9/1/2023
  • Lot 57686883 exp 10/1/2023

Distribution

Distribution scope not specified by the agency.

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