The Recall Desk
HighFDA (Devices)·Z-0712-2023·Announced 2022-12-21

DeRoyal Cataract Pack Surgical Kit Class II Recall

DeRoyal Industries has recalled the DeRoyal CATARACT PACK (368 kits) in a voluntary Class II recall. Affected lot numbers are 55990451 and 56615717 with expiration 08/01/2024.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. Per the severity rubric, Class II recalls with hospitalization reports score as Severe, but this recall contains no such reports. The rubric classifies risk-of-harm products without reported injury as High.

Plain-English summary

DeRoyal Industries Inc. issued a voluntary recall of the DeRoyal CATARACT PACK, Reference 89-9241.03, in a Class II recall affecting 368 surgical kits. The recall involves two lot numbers: 55990451 and 56615717, both with expiration dates of August 1, 2024.

The recalled product was distributed across multiple 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 facilities and providers that received this product should contact DeRoyal Industries Inc. for instructions on handling the recalled units. Patients who may have been treated with equipment from this recall should consult their healthcare provider if they have concerns.

The recalled product

Product
DeRoyal CATARACT PACK, REF 89-9241.03
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Equipment
Affected units
368

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 (2)

  • Lot Numbers: 55990451 exp 08/01/2024
  • 56615717 exp 08/01/2024

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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