Medical Device Recall: DeRoyal Shoulder Arthroscopy Pack Kits
DeRoyal Industries initiated a voluntary recall of 363 shoulder arthroscopy surgical packs. The specific reason for the recall was not disclosed in the notice.
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 voluntary precautionary recall initiated by the manufacturer with no reported illnesses, injuries, or deaths. The specific hazard was not disclosed in the recall notice. Voluntary recalls without evidence of harm fall within the Moderate severity category.
Plain-English summary
DeRoyal Industries Inc has initiated a voluntary recall of the DeRoyal SHOULDER ARTHROSCOPY PACK (Model REF 89-9946.04). The recall affects 363 surgical kits from three production lots.
The affected lots are: Lot 56394580 (expiration 10/1/2024), Lot 56780181 (expiration 12/1/2024), and Lot 56822791 (expiration 11/1/2024). The specific reason for the recall was not disclosed in the recall documentation.
The recalled kits were distributed to healthcare facilities in 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.
Healthcare providers and hospitals that received these kits should contact DeRoyal Industries Inc at their Powell, Tennessee facility or through their medical device supplier for handling instructions regarding the recalled products.
The recalled product
- Product
- DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-9946.04
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Orthopedic
- Affected units
- 363
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 56394580 exp 10/1/2024
- Lot 56780181 exp12/1/2024
- Lot 56822791 exp 11/1/2024
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.
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
- ModerateDeRoyal Recalls Surgical Kits Due to Missing Protective Tape
FDA (Devices) · 2012-07-25
- HighDeRoyal recalls custom sterile surgical packs with Terumo valve defect
FDA (Devices) · 2018-02-28
- HighMedical Procedure Packs with Compromised Package Seals Recalled
FDA (Devices) · 2023-07-12