FDA recalls DeRoyal shoulder arthroscopy surgical packs
DeRoyal Industries Inc has voluntarily recalled shoulder arthroscopy surgical packs distributed across 22 US states. The specific reason for recall was not disclosed in the FDA notification.
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 initiated voluntarily with no reported illnesses, injuries, or deaths mentioned in the source. Per the rubric, voluntary recalls without documented harm and with an undisclosed specific hazard warrant a Moderate classification.
Plain-English summary
DeRoyal Industries Inc initiated a voluntary recall of DeRoyal SHOULDER ARTHROSCOPY PACK (REF 89-10061.02) in November 2022. This is an FDA Class II recall involving surgical equipment used in shoulder procedures.
Three lot numbers are affected: Lot 55972430 (expiration 10/1/2022), Lot 56621455 (expiration 11/1/2023), and Lot 57302780 (expiration 2/1/2024). The products were distributed to healthcare facilities in Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, and Georgia.
The FDA notification did not specify the underlying reason for the recall. Healthcare facilities that received these products should verify their inventory against the affected lot numbers and contact DeRoyal Industries Inc for further instructions and guidance on product replacement or return.
The recalled product
- Product
- DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10061.02
- Manufacturer
- DeRoyal Industries Inc
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 (3)
- Lot Numbers: Lot 55972430 exp 10/1/2022
- Lot 56621455 exp 11/1/2023
- Lot 57302780 exp 2/1/2024
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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