Voluntary Recall of DeRoyal Biopsy Pack Medical Device Kits
DeRoyal Industries initiated a voluntary recall of 560 biopsy pack kits (lot 56094211) distributed across multiple US states. The specific reason for the recall was not documented in the available source.
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 Class II FDA device recall initiated voluntarily by the manufacturer. No illnesses, injuries, or fatalities are reported in the source documentation, and the specific hazard or reason for recall is not documented. Voluntary recalls without identified adverse events or stated risk details are classified as Moderate.
Plain-English summary
DeRoyal Industries Inc is recalling 560 units of the DeRoyal BIOPSY PACK (REF 89-9270.04), lot 56094211, with an expiration date of May 1, 2024. This is a voluntary, manufacturer-initiated recall classified as FDA Class II.
The affected biopsy pack kits were distributed across the United States, including 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 recall was initiated on November 3, 2022, and was ongoing as of the report date of December 21, 2022.
The source documentation does not specify the reason for this recall. Healthcare facilities and medical professionals who received biopsy packs from this lot should contact DeRoyal Industries Inc for further guidance and instructions regarding the affected inventory.
The recalled product
- Product
- DeRoyal BIOPSY PACK, REF 89-9270.04
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 560
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 56094211 exp 5/1/2024
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
- SevereDeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination
FDA (Devices) · 2020-03-11
- HighDeRoyal Sterile Custom Kits Recalled for Unknown Contamination Levels
FDA (Devices) · 2020-03-11
- HighDeRoyal and GEO-MED sterile surgical kits recalled for seal defects
FDA (Devices) · 2015-12-09
- HighDeRoyal surgical procedure pack recalled for sterile barrier defect
FDA (Devices) · 2023-01-18
- ModerateDeRoyal Knee Arthroscopy Pack Recalled Due to Component Recall
FDA (Devices) · 2014-08-06
- HighDeRoyal Open Heart Packs Recalled Due to Non-Sterile Sternum Saw Blades
FDA (Devices) · 2021-03-03