DeRoyal Cataract Procedure Packs Recalled Due to Affected 3M Steri Drapes
DeRoyal Industries is recalling 190 cataract procedure packs that contain 3M Health Care Steri Drapes which have been recalled. The affected packs were distributed across 22 US states.
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 Class II medical device recall with no reported illnesses, injuries, or specific hazard identified in the source material. The recall is secondary in nature—a product containing a recalled component. With no reported adverse events and no stated hazard details, this falls within the range of Class II recalls without additional severity indicators.
Plain-English summary
DeRoyal Industries Inc. is recalling DeRoyal CATARACT PACK kits (REF 89-7135.10) that contain 3M Health Care Steri Drapes that are the subject of a recall by 3M Health Care.
The recall involves 190 procedure packs. Affected lot numbers are 57312291 (with expiration date 12/1/2024), 57500604, 56043472, and 57894789.
The affected packs were distributed to healthcare facilities across 22 US 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.
Further information regarding the specific reason for this recall and recommended actions should be obtained from DeRoyal Industries Inc. or the FDA.
The recalled product
- Product
- DeRoyal CATARACT PACK, REF 89-7135.10
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 190
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 (4)
- Lot Numbers: Lot 57312291 exp 12/1/2024
- Lot 57500604 exp ***
- Lot 56043472 exp ***
- Lot 57894789 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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