The Recall Desk
ModerateFDA (Devices)·Z-0622-2023·Announced 2022-12-21

FDA Class II Medical Device Recall: GEO-MED Biopsy Tray

DeRoyal Industries Inc voluntarily recalled approximately 460 units of GEO-MED BIOPSY TRAY distributed across 23 US states. The specific reason for the recall is not disclosed in available FDA documentation.

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 medical device recall initiated voluntarily by the manufacturer with no reported illnesses, injuries, or hospitalizations documented in the source. FDA Class II recalls require attention but carry moderate risk; the absence of reported harm supports a Moderate severity rating per the rubric.

Plain-English summary

DeRoyal Industries Inc, a medical device manufacturer in Powell, Tennessee, initiated a voluntary recall of the GEO-MED BIOPSY TRAY (REF 89-8753.01) beginning in November 2022. Approximately 460 units were distributed to healthcare facilities in 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 affected product includes two lot numbers: Lot 56005548 with expiration 6/1/2023 and Lot 57005363 with expiration 7/1/2023. The specific reason for this FDA Class II recall is not disclosed in the published source documentation.

Healthcare providers and facilities in affected states who have received this product should verify their inventory against the lot numbers provided and contact DeRoyal Industries Inc or their supplier for recall instructions. No specific action guidance for end users has been disclosed.

The recalled product

Product
GEO-MED BIOPSY TRAY, REF 89-8753.01
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical / Biopsy Equipment
Hazard
  • device-defect

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 56005548 exp 6/1/2023
  • Lot 57005363 exp 7/1/2023

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category