The Recall Desk
ModerateFDA (Devices)·Z-0710-2023·Announced 2022-12-21

Surgical Supply Recall: DeRoyal Cataract Pack Class II 440 Kits

DeRoyal Industries is voluntarily recalling 440 kits of its Cataract Pack (Model 89-8650.10, Lot 55749537). The FDA classified this as a Class II device recall, but the specific reason is not provided in the 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 device recall initiated voluntarily by the manufacturer with no reported illnesses or injuries. The rubric identifies voluntary precautionary recalls as Score 2 (Moderate).

Plain-English summary

DeRoyal Industries Inc is recalling the DeRoyal Cataract Pack (Reference 89-8650.10), specifically Lot Number 55749537 which expires August 1, 2023. The total quantity recalled is 440 kits. The specific reason for the recall is not provided in the FDA recall notice.

The affected kits were distributed to customers in 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.

The recall was initiated on November 3, 2022, and the FDA classified it as a Class II device recall on December 15, 2022. This recall was initiated voluntarily by the manufacturer. For further information or to report any adverse events related to this product, affected customers should contact DeRoyal Industries Inc.

The recalled product

Product
DeRoyal CATARACT PACK, REF 89-8650.10
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Ophthalmic Surgical Supply
Affected units
440

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: 55749537 exp 08/01/2023

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

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