DeRoyal Cataract Surgery Packs Recalled for Defective Components
DeRoyal cataract procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. The recall includes 520 kits distributed to healthcare facilities.
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 recall of medical devices used in surgical procedures. The recall involves defective components that present a risk of harm in a surgical setting, with no reported illnesses mentioned in the source material.
Plain-English summary
DeRoyal Industries Inc. is recalling cataract procedure packs (Model REF 89-10086.05) that contain 3M Health Care Steri Drapes which have been separately recalled.
The affected recall includes 520 kits distributed to healthcare facilities in multiple US states including 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 specific lot numbers affected are: 57003552 (expiration 09/01/2024), 57467226 (expiration 12/01/2024), 55748075, 56250244, 57899344, and 57913353. Healthcare facilities that have received these kits should check their inventory and follow the manufacturer's guidance regarding the recalled Steri Drapes.
The recalled product
- Product
- DeRoyal CATARACT PACK, REF 89-10086.05
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 520
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 (6)
- Lot Numbers: 57003552 exp 09/01/2024
- 57467226 exp 12/01/2024
- 55748075 exp *
- 56250244 exp *
- 57899344 exp *
- 57913353 exp *
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 →- 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
- HighDeRoyal Children's Surgical Pack Recalled for Smoke Pencil Malfunction
FDA (Devices) · 2024-11-13
Same hazard · defective component
See all →- HighBeckman Coulter Sample Probes with Defective Tips Clinical Chemistry
FDA (Devices) · 2025-06-11
- SevereMedline Medical Convenience Kits Recalled for Defective Endotracheal Tubes
FDA (Devices) · 2025-04-16
- SevereMedline Medical Procedure Kits with Medtronic Aortic Cannula Recalled
FDA (Devices) · 2025-04-16
- SevereExactech AcuMatch XLE Hip Implant Liner Recall
FDA (Devices) · 2025-02-19
- ModerateMedline Medical Convenience Kits Recall Due to Recalled Component
FDA (Devices) · 2024-12-11