DeRoyal Knee Arthroscopy Packs Recalled Due to Affected Sterile Drape Component
DeRoyal Industries is recalling GEO-MED KNEE ARTHROSCOPY PACK units containing 3M Health Care Steri Drapes due to a supplier recall. No reported illnesses or injuries.
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: FDA Class II medical device recall triggered by a supplier's recall of a component. No reported illnesses, injuries, or specific identified hazard; this is a precautionary recall.
Plain-English summary
DeRoyal Industries Inc. is recalling GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07, due to the inclusion of 3M Health Care Steri Drapes that have been recalled by the supplier. The recall affects procedure packs in Lot 56822290 (expiration 2/1/2025).
The affected packs were distributed to medical 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.
DeRoyal is notifying customers and distributors. Healthcare providers who have received these procedure packs should not use them and should contact DeRoyal Industries Inc. for instructions on return or replacement.
The recalled product
- Product
- GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 4
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 (1)
- Lot Numbers: Lot 56822290 exp 2/1/2025
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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