Surgical Kit Recall: DeRoyal Shoulder Arthroscopy Pack Class II
DeRoyal Industries initiated a Class II recall of 100 shoulder arthroscopy surgical kits distributed across 23 U.S. states. The specific defect has not been publicly disclosed in FDA records.
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 initiated voluntarily by manufacturer with no reported illnesses, injuries, or deaths documented. Voluntary, precautionary nature without reported harm aligns with rubric criteria for Moderate severity.
Plain-English summary
DeRoyal Industries Inc. has recalled the DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-8777.04, a Class II medical device. The recall affects 100 kits with lot numbers 56781336 (expiring 11/1/2024) and 56882647 (expiring 10/1/2024).
The surgical 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. DeRoyal initiated the voluntary recall on November 3, 2022, notifying affected parties through email, fax, letters, press releases, telephone communication, and direct facility visits.
The FDA formally classified the recall on December 15, 2022. As of available records, the recall status remains ongoing. The specific defect or hazard that prompted this Class II recall has not been publicly disclosed in the FDA database.
The recalled product
- Product
- DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-8777.04
- 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 (2)
- Lot Numbers: Lot 56781336 exp 11/1/2024
- Lot 56882647 exp 10/1/2024
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