The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0662-2023·Announced 2022-12-21

FDA Class II Recall: DeRoyal BIOPSY PACK Medical Device

DeRoyal Industries has recalled 480 units of its BIOPSY PACK (REF 89-9614.07) in a voluntary, firm-initiated recall affecting 23 US states. The specific reason for the recall has not been disclosed.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall for a product used in invasive surgical procedures (biopsies), which inherently carry risk of potential harm. No illnesses or injuries have been reported. The classification meets the rubric criterion for high severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

DeRoyal Industries Inc has recalled 480 units of the DeRoyal BIOPSY PACK (REF 89-9614.07), an FDA Class II medical device. The affected product was distributed across 23 US 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 recall was initiated voluntarily by DeRoyal Industries Inc on November 3, 2022, with FDA classification on December 15, 2022. The specific reason for the recall has not been provided in the agency documentation. The affected lot numbers are: Lot 56584885 (expiration 9/1/2024), Lot 57030745 (expiration 2/1/2025), and Lot 57686461 (expiration 5/1/2025).

Healthcare facilities and individuals who have received or are using this product should contact DeRoyal Industries Inc for recall instructions and guidance. The company has notified customers through email, fax, letter, press release, telephone, and on-site visits.

The recalled product

Product
DeRoyal BIOPSY PACK, REF 89-9614.07
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical / Biopsy
Affected units
480

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 56584885 exp 9/1/2024
  • Lot 57030745 exp 2/1/2025
  • Lot 57686461 exp 5/1/2025

Distribution

Distributed in 23 states:

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 →

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