The Recall Desk
ModerateFDA (Devices)·Z-0603-2023·Announced 2022-12-21

DeRoyal EYE TRAY Procedure Packs Recalled Due to 3M Steri Drape Recall

DeRoyal Industries is recalling EYE TRAY procedure packs containing recalled 3M Health Care Steri Drapes. The recall affects 180 kits distributed across multiple U.S. states.

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 medical device recall with no reported illnesses or injuries documented in the source. The specific hazard related to the recalled 3M component is not detailed in this notice.

Plain-English summary

DeRoyal Industries Inc. is recalling DeRoyal EYE TRAY PGYBK (REF 89-7978.02) procedure packs because they contain 3M Health Care Steri Drapes that have been recalled by the manufacturer.

A total of 180 procedure packs containing the affected component were distributed throughout the United States. Distribution included the following 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 affected lot number is Lot 56394686, which expires July 1, 2024.

Users who have received these procedure packs should immediately discontinue use of the affected lot. Contact DeRoyal Industries Inc. for instructions on returning or replacing the product.

The recalled product

Product
DeRoyal EYE TRAY PGYBK, REF 89-7978.02
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Supplies

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 (1)

  • Lot Numbers: Lot 56394686 exp 7/1/2024

Distribution

Distribution scope not specified by the agency.

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