The Recall Desk
ModerateFDA (Devices)·Z-0636-2023·Announced 2022-12-21

DeRoyal BASIC EYE PACK Medical Device Voluntary Recall

DeRoyal BASIC EYE PACK (Lot 57389942) was voluntarily recalled as a Class II medical device on November 3, 2022. The specific reason for recall is not disclosed in the FDA notice.

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 voluntary, firm-initiated recall. No illnesses or injuries reported in the notice. Specific hazard is not disclosed in the source material, limiting severity assessment to moderate level.

Plain-English summary

DeRoyal BASIC EYE PACK (REF 89-9233.08) was voluntarily recalled by manufacturer DeRoyal Industries Inc on November 3, 2022. The recall involves 60 kits with Lot Number 57389942 (expiration September 1, 2024).

The FDA classified this as a Class II recall, indicating potential health consequences, though the specific reason for the recall is not disclosed in the available FDA notice.

The product was distributed to healthcare facilities and suppliers across 23 U.S. 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.

Healthcare providers and patients who have received this product should check if they have Lot 57389942 and contact the manufacturer for further information regarding the recall status and any necessary replacement procedures.

The recalled product

Product
DeRoyal BASIC EYE PACK, REF 89-9233.08
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Eye Care
Affected units
60

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 57389942 exp 9/1/2024

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 →

Related recalls

Same manufacturer · DeRoyal Industries Inc

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