DeRoyal cataract pack (Model 89-9241.04) recalled by FDA
DeRoyal Industries initiated a voluntary recall of 552 units of its CATARACT PACK due to an unspecified defect. The FDA classified this Class II recall on December 15, 2022.
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 an FDA Class II medical device recall initiated voluntarily by the manufacturer with no reported illnesses, injuries, or deaths. The absence of documented hazard details and harm reports, combined with the voluntary nature of the recall, supports a Moderate classification consistent with precautionary device recalls.
Plain-English summary
DeRoyal Industries Inc. initiated a voluntary recall of 552 units of the DeRoyal CATARACT PACK, Model REF 89-9241.04, on November 3, 2022. The FDA classified the recall as Class II on December 15, 2022 (recall number Z-0713-2023).
The specific reason for the recall has not been documented in the available FDA recall notice. Three lot numbers are identified in the recall: 57198898 (expiration 12/01/2024), 57686605 (expiration 04/01/2025), and 57754049 (expiration date not specified).
The affected product was 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.
Consumers who possess affected units should contact DeRoyal Industries Inc. at 200 Debusk Lane, Powell, Tennessee 37849-4703 for further information and recall instructions.
The recalled product
- Product
- DeRoyal CATARACT PACK, REF 89-9241.04
- Manufacturer
- DeRoyal Industries Inc
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: 57198898 exp 12/01/2024
- 57686605 exp 04/01/2025
- 57754049 exp
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03