Medical Device Recall: DeRoyal Shoulder Arthroscopy Pack
A voluntary recall of 56 kits of DeRoyal Shoulder Arthroscopy Packs (Model 89-10240.03, Lot 56465579) was initiated by DeRoyal Industries. The FDA classified this Class II recall, which affected multiple U.S. states.
What this means for you
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 device recall with voluntary firm initiation and no reported illnesses or injuries. Without a specified hazard disclosed in the source material, the recall cannot be elevated to higher severity.
Plain-English summary
DeRoyal Industries Inc. initiated a voluntary recall of the DeRoyal Shoulder Arthroscopy Pack, Model 89-10240.03 (Lot 56465579, expiration 7/1/2026). A total of 56 kits were affected and the recall was initiated on November 3, 2022.
The FDA classified this as a Class II recall. The specific reason for this recall was not specified in the available source material.
The affected kits were distributed across 23 U.S. 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. The product is used in shoulder arthroscopy surgical procedures.
The recalled product
- Product
- DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 56
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 56465579 exp 7/1/2026
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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