The Recall Desk
ModerateFDA (Devices)·Z-0682-2023·Announced 2022-12-21

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.

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 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
Category
Medical Device — Surgical Equipment

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

Distribution scope not specified by the agency.

Related recalls

Same category