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.
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 3/5 (High).
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.
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