Medical Device Recall: DeRoyal Shoulder Arthroscopy Pack
A voluntary recall of 56 kits of DeRoyal Shoulder Arthroscopy Packs (Model 89-10240.03, Lot 56465579) was initiated by DeRoyal Industries. The FDA classified this Class II recall, which affected multiple 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: FDA Class II device recall with voluntary firm initiation and no reported illnesses or injuries. Without a specified hazard disclosed in the source material, the recall cannot be elevated to higher severity.
Plain-English summary
DeRoyal Industries Inc. initiated a voluntary recall of the DeRoyal Shoulder Arthroscopy Pack, Model 89-10240.03 (Lot 56465579, expiration 7/1/2026). A total of 56 kits were affected and the recall was initiated on November 3, 2022.
The FDA classified this as a Class II recall. The specific reason for this recall was not specified in the available source material.
The affected 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 product is used in shoulder arthroscopy surgical procedures.
The recalled product
- Product
- DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 56
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 56465579 exp 7/1/2026
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.
See all 156 products in this recall →Related recalls
Same manufacturer · DeRoyal Industries Inc
See all →- ModerateDeRoyal Myocardial Probe Recall Due to Incorrect Needle Length
FDA (Devices) · 2026-09-30
- ModerateVascular Access Dressing Recalled Due to Lack of Sterility Assurance
FDA (Devices) · 2026-06-10
- HighDeRoyal Suction Connector Tubing Recalled for Assembly and Function Issues
FDA (Devices) · 2025-03-12
- HighDeRoyal AMG Suction Connector Tubing connection may fail to seal
FDA (Devices) · 2025-02-26
- HighDeRoyal Children's Orthopedic Tracepack Smoke Evacuation Pencil Malfunction Recall
FDA (Devices) · 2024-11-13
Similar recalls
- ModerateDeRoyal Knee Arthroscopy Pack Recalled Due to Component Recall
FDA (Devices) · 2014-08-06
- ModerateDeRoyal Recalls Sterile Surgical Kits Due to Expired Prep Pads
FDA (Devices) · 2018-01-24
- SevereCustomed Recalls Shoulder Arthroscopy Packs Due to Sterility Compromise
FDA (Devices) · 2014-12-10
- SevereDeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination
FDA (Devices) · 2020-03-11
- HighMedical Procedure Packs with Compromised Package Seals Recalled
FDA (Devices) · 2023-07-12
- CriticalCustomed Recalls Shoulder Arthroscopy Packs Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10