The Recall Desk
ModerateFDA (Devices)·Z-0714-2023·Announced 2022-12-21

Cataract surgical pack Class II recall issued

DeRoyal CATARACT PACK surgical kits are subject to a voluntary Class II recall affecting 108 kits across 23 U.S. states. The specific reason for the recall is not provided in available 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: This is a voluntary, firm-initiated Class II medical device recall with no documented specific hazard or reported injuries and illnesses. Per the severity rubric, voluntary precautionary recalls are classified as Moderate.

Plain-English summary

DeRoyal Industries Inc. has initiated a voluntary Class II recall of the DeRoyal CATARACT PACK, REF 89-10040.01, a medical device used in cataract surgical procedures. The recall affects 108 kits distributed 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.

Affected lot numbers are 56125881 (expiration May 1, 2026), 56618926 (expiration May 1, 2026), and 57485029 (expiration November 1, 2026). The specific reason for this recall is not documented in the FDA source materials. Healthcare facilities in possession of affected units should contact DeRoyal Industries Inc. for further information and instructions.

The recalled product

Product
DeRoyal CATARACT PACK, REF 89-10040.01
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical / Ophthalmic
Affected units
108

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: 56125881 exp 05/01/2026
  • 56618926 exp 05/01/2026
  • 57485029 exp 11/01/2026

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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