DeRoyal SHOULDER PACK Medical Device Recall Class II
DeRoyal Industries Inc is recalling 876 kits of the DeRoyal SHOULDER PACK (REF 89-6830.13) due to an unspecified reason for recall. The affected product was distributed across 23 U.S. 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 an FDA Class II recall for a medical device. The source does not indicate reported hospitalizations, injuries, or illnesses. With no adverse events reported and only a theoretical risk, this falls into the Moderate category per the rubric.
Plain-English summary
DeRoyal Industries Inc is recalling the DeRoyal SHOULDER PACK, REF 89-6830.13, a medical device. Approximately 876 kits are affected by this voluntary recall, which was initiated by the firm on November 3, 2022.
The affected product was distributed across the United 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.
Consumers who have received this product should contact DeRoyal Industries Inc. The recall involves the following lot numbers and expiration dates: Lot 56184005 (exp 11/1/2023), Lot 56254392 (exp 10/1/2023), Lot 56777927 (exp 1/1/2024), Lot 57391031 (exp 2/1/2024), and Lot 57684204 (exp 5/1/2024). The FDA classified this as a Class II recall.
The recalled product
- Product
- DeRoyal SHOULDER PACK, REF 89-6830.13
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 876
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 (5)
- Lot Numbers: Lot 56184005 exp 11/1/2023
- Lot 56254392 exp 10/1/2023
- Lot 56777927 exp 1/1/2024
- Lot 57391031 exp 2/1/2024
- Lot 57684204 exp 5/1/2024
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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