Medical Device Shoulder Pack Recall Initiated by Manufacturer
DeRoyal Industries initiated a voluntary recall of 32 kits of its Shoulder Pack medical device distributed across 23 U.S. states. The specific reason for the recall was not provided in the source documentation.
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 recall with no reported illnesses or injuries documented in the source material. The specific hazard or reason for recall was not provided in the available documentation, warranting a Moderate classification per the rubric for voluntary recalls without documented harm.
Plain-English summary
DeRoyal Industries Inc. initiated a voluntary recall of its Shoulder Pack medical device (REF 89-9449.12) on November 3, 2022. A total of 32 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 affected product carries Lot Number 56616218 with an expiration date of December 1, 2024.
The FDA classified this as a Class II recall on December 15, 2022. The specific reason for the recall was not documented in the available source material. The manufacturer initiated this action voluntarily and notified customers through multiple channels including email, fax, letter, press release, telephone, and direct visits.
Healthcare facilities or individuals with possession of this product should contact DeRoyal Industries Inc. at 200 Debusk Lane, Powell, Tennessee 37849-4703 for further instructions regarding the affected devices.
The recalled product
- Product
- DeRoyal SHOULDER PACK, REF 89-9449.12
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device
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 56616218 exp 12/1/2024
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03