Leica Biosystems 38440501Recalls & reported problems

Leica Biosystems Richmond, Inc. · IP Biopsy Cassette II with lid, Taped, Pink · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20849832022095), received between Nov 6, 2025 and Apr 23, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break2
Adverse Event Without Identified Device or Use Problem1

Patient problems

Insufficient Information2
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 23, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS AND REPORTED "...A CASSETTE LID BROKE AND TISSUE ESCAPED DURING PROCESSING AND WAS LOST." NO ADVERSE IMPACT TO ANY PATIENT HAS BEEN REPORTED TO THE MANUFACTURER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24973940 ↗
MalfunctionNov 6, 2025Break; Break
ON 13 OCTOBER 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "ON-SITE WITH CUSTOMER ON (B)(6) 2025. MANAGER [NAME] INFORMED ME OF ISSUE WITH 38440501: IP BIOPSY CASSETTE II, TAPED, PINK. FLANGE HAS BEEN BREAKING OFF, CASSETTES OPENING DURING PROCESSING, AND TISSUE HAS BEEN LOST. ISSUE HAS OCCURRED ALL WEEK WHERE TISSUE IS BEING LOST. PER [NAME], THIS HAS OCCURRED WITH 3 DIFFERENT PAS EVEN AFTER PARTICULAR CARE IS BEING TAKEN. PAS FEEL THAT CASSETTES SEEM "SOFTER" AND MORE FRAGILE THAN PREVIOUSLY. SWITCHED TO NEW LOT# AND TAKING EXTRA PRECAUTIONS. THIS SITE IS ALSO USING THE SAME CASSETTE IN GREEN AND YELLOW, NO REPORTED ISSUES." NO ADVERSE IMPACT TO A PATIENT HAS BEEN REPORTED TO THE MANUFACTURER.
Patient problems: Insufficient Information
MAUDE report 23491128 ↗
MalfunctionNov 6, 2025Break; Break
ON (B)(6) 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "ON-SITE WITH CUSTOMER ON (B)(6) 2025. MANAGER [NAME] INFORMED ME OF ISSUE WITH 38440501: IP BIOPSY CASSETTE II, TAPED, PINK. FLANGE HAS BEEN BREAKING OFF, CASSETTES OPENING DURING PROCESSING, AND TISSUE HAS BEEN LOST. ISSUE HAS OCCURRED ALL WEEK WHERE TISSUE IS BEING LOST. PER [NAME], THIS HAS OCCURRED WITH 3 DIFFERENT PAS EVEN AFTER PARTICULAR CARE IS BEING TAKEN. PAS FEEL THAT CASSETTES SEEM "SOFTER" AND MORE FRAGILE THAN PREVIOUSLY. SWITCHED TO NEW LOT # AND TAKING EXTRA PRECAUTIONS. THIS SITE IS ALSO USING THE SAME CASSETTE IN GREEN AND YELLOW, NO REPORTED ISSUES." NO ADVERSE IMPACT TO A PATIENT HAS BEEN REPORTED TO THE MANUFACTURER.
Patient problems: Insufficient Information
MAUDE report 23491120 ↗

Device details

UDI-DI	`20849832022095`
Brand	Leica Biosystems
Model	38440501
Company	Leica Biosystems Richmond, Inc.
Product code	IDZ · CASSETTES, TISSUE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 28, 2025

Device type (GMDN): Histology tissue cassette IVD, laboratory processing, single-use

A small device intended to be used in the laboratory to support/contain clinical tissue specimens (e.g., biopsy samples) to facilitate specimen processing [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination, and storage. It is in the form of a plastic container, with or without a lid, with drainage holes to maximize fluid exposure during tissue submersion in a parent device into which the container is loaded. It may, in addition, include a fenestrated insert to hold and prevent the loss of a smaller specimens. This is a single-use device.

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All CASSETTES, TISSUE devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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