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
- defective-component
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
Distribution scope not specified by the agency.
Related recalls
Same category
- ModerateMedline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- SevereMedline angiography and radiology convenience kits recalled for unapproved design changes
FDA (Devices) · 2026-07-01