The Recall Desk
ModerateFDA (Devices)·Z-0664-2023·Announced 2022-12-21

FDA Issues Class II Recall of DeRoyal Biopsy Pack Kits

DeRoyal Industries has voluntarily recalled 180 units of its Biopsy Pack (Lot 56842514, exp. 8/1/2026) following an FDA Class II classification. The product was distributed across 23 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: This is an FDA Class II recall voluntarily initiated by the manufacturer. No illnesses, injuries, or specific hazard has been reported or disclosed. The classification indicates a precautionary measure rather than an immediate threat to public health.

Plain-English summary

DeRoyal Industries Inc. has initiated a voluntary recall of 180 units of the DeRoyal Biopsy Pack (Reference 89-9739.05, Lot 56842514, expiration date 8/1/2026) following an FDA Class II determination.

The affected biopsy pack 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.

No illnesses or injuries have been reported in connection with this recall. The specific reason for the recall has not been disclosed in the source material. Customers who have received this product should contact DeRoyal Industries Inc. or their healthcare provider for guidance.

The recalled product

Product
DeRoyal BIOPSY PACK, REF 89-9739.05
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical / Biopsy Supplies

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 56842514 exp 8/1/2026

Distribution

Distribution scope not specified by the agency.

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