FDA Recalls DeRoyal Shoulder Kit Medical Device across 23 states
DeRoyal Industries recalled 28 SHOULDER KIT units due to an unspecified Class II device defect. The affected lot numbers were distributed across 23 U.S. states between November 2022 and April 2025.
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 recalls with voluntary firm initiation and no reported illnesses or injuries indicate correctable defects requiring attention but without documented patient harm. The specific hazard nature is not specified in the source recall documentation.
Plain-English summary
DeRoyal Industries initiated a voluntary recall of 28 SHOULDER KIT units (Reference 89-9497.10) beginning November 3, 2022. The FDA classified this as a Class II recall on December 15, 2022. The specific defect leading to the recall is not detailed in the available recall notice.
The affected lot numbers are Lot 576900006 (expiration 4/1/2025) and Lot 57770532 (expiration 4/1/2025). These kits were distributed to healthcare facilities 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.
No illnesses or injuries have been reported in connection with this recall. DeRoyal Industries notified affected customers through email, fax, letter, press release, telephone, and direct facility visits. Healthcare providers and consumers in possession of affected units should contact DeRoyal Industries for further instructions regarding the defective product.
The recalled product
- Product
- DeRoyal SHOULDER KIT, REF 89-9497.10
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device
- Hazard
- device-defect
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 (2)
- Lot Numbers: Lot 576900006 exp 4/1/2025
- Lot 57770532 exp 4/1/2025
Distribution
Distribution scope not specified by the agency.
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