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.
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: 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
- 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
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
See all →- ModerateDeRoyal Myocardial Probe Recall Due to Incorrect Needle Length
FDA (Devices) · 2026-09-30
- ModerateVascular Access Dressing Recalled Due to Lack of Sterility Assurance
FDA (Devices) · 2026-06-10
- HighDeRoyal Suction Connector Tubing Recalled for Assembly and Function Issues
FDA (Devices) · 2025-03-12
- HighDeRoyal AMG Suction Connector Tubing connection may fail to seal
FDA (Devices) · 2025-02-26
- HighDeRoyal Children's Orthopedic Tracepack Smoke Evacuation Pencil Malfunction Recall
FDA (Devices) · 2024-11-13
Similar recalls
- SevereCustomed Recalls Cataract Packs Due to Sterility Compromise
FDA (Devices) · 2014-12-10
- HighWindstone Medical Recalls Cataract Packs Due to Sterile Packaging Concerns
FDA (Devices) · 2017-04-19
- ModerateEye Surgery Kit Recall Due to Defective Surgical Drapes
FDA (Devices) · 2022-11-30
- HighSurgical Cataract Pack Recalled Due to Compromised Sterile Packaging
FDA (Devices) · 2022-11-09
- ModerateDeRoyal Sterile Custom Kits Recalled for Defective Connectors
FDA (Devices) · 2022-09-07
- ModerateEye Surgery Convenience Kits Recalled for Defective Surgical Drapes
FDA (Devices) · 2022-11-30