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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- 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
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.
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