DeRoyal Biopsy Pack medical device recall: Class II voluntary
DeRoyal Industries voluntarily recalled 1200 biopsy pack kits distributed across 23 U.S. states. The reason for the recall was not disclosed in available source material.
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 voluntary medical device recall where the specific reason was not disclosed in available materials. Per the severity rubric, voluntary firm-initiated recalls of Class II devices without stated health hazard typically receive a Moderate classification.
Plain-English summary
DeRoyal Industries Inc initiated a voluntary recall of 1200 DeRoyal BIOPSY PACK kits (model REF 89-9270.05) beginning November 3, 2022. The recall includes two lot numbers: Lot 57119598 (expiration 8/1/2024) and Lot 57754111 (expiration 10/1/2024).
The specific reason for this Class II recall was not disclosed in 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. Healthcare providers and facilities that received these kits should contact DeRoyal Industries Inc or their distributor for guidance on next steps.
The recalled product
- Product
- DeRoyal BIOPSY PACK, REF 89-9270.05
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 1,200
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 57119598 exp 8/1/2024
- Lot 57754111 exp 10/1/2024
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.
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