The Recall Desk
ModerateFDA (Devices)·Z-0564-2023·Announced 2022-12-21

DeRoyal EYE TRAY Procedure Packs Recalled for Defective 3M Steri Drapes

DeRoyal Industries is recalling 48 kits of EYE TRAY procedure packs that contain 3M Health Care Steri Drapes which have been recalled.

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 FDA Class II medical device recall indicates the product may cause temporary or medically reversible adverse effects. The specific defect is not detailed in the recall notice, and no reported illnesses or injuries are mentioned.

Plain-English summary

DeRoyal Industries is recalling 48 kits of the DeRoyal EYE TRAY procedure pack (Reference 89-4957.08, Lot 55646968, expiring June 1, 2023). These procedure packs contain 3M Health Care Steri Drapes, which have been recalled.

The recalled procedure packs were distributed to healthcare facilities across the United States, including in 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 specific reason for the Steri Drapes recall is not detailed in the available recall notice. No reported illnesses or injuries are mentioned. Facilities that received these procedure packs should stop using them and contact DeRoyal Industries for guidance on replacement or return.

The recalled product

Product
DeRoyal EYE TRAY, REF 89-4957.08
Manufacturer
DeRoyal Industries Inc

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 55646968 exp 6/1/2023

Distribution

Distribution scope not specified by the agency.