Tissue-Tek AutoTEC® a120 7090Recalls & reported problems

Sakura Finetek U.S.A., Inc. · Automated Embedder · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04946433600362), received between Oct 20, 2023 and Sep 23, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Use of Device Problem2
Improper or Incorrect Procedure or Method1

Patient problems

Insufficient Information2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjurySep 23, 2026Use of Device Problem; Improper or Incorrect Procedure or Method
Patient problems: Insufficient Information
MAUDE report 50873631 ↗
InjuryOct 20, 2023Use of Device Problem; Use of Device Problem
ON (B)(6) 2023 A CUSTOMER REPORTED TO SAKURA FIELD TECHNICAL SUPPORT (FTS) AGENT THAT A CASSETTE CAME OUT OF THE TISSUE-TEK AUTOTEC A120 INSTRUMENT WITHOUT A LID WHICH CAUSED A TISSUE LOSS. BECAUSE IT APPEARED THE LID WAS OFF PRIOR TO THE CASSETTE GETTING TO ACTUAL EMBEDDING, THE INSTRUMENT DIDN'T ERROR FOR A LOOSE LID. DUE TO THE TISSUE LOSS, A PATIENT WILL HAVE TO UNDERGO A RE-BIOPSY.
Patient problems: Insufficient Information
MAUDE report 17981196 ↗

Device details

UDI-DI	`04946433600362`
Brand	Tissue-Tek AutoTEC® a120
Model	7090
Company	Sakura Finetek U.S.A., Inc.
Product code	IDW · DISPENSERS, PARAFFIN
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 4, 2020

Device type (GMDN): Tissue embedding unit IVD

An electrically-powered, electronic unit intended to be used in the laboratory for encapsulating (embedding) histologic tissue samples in liquid paraffin wax which when cooled and fixed to a sample holder can be further processed, e.g., placed in a microtome for cutting into samples for microscopy and/or for histological storage. This device will typically have a large storage capacity for the liquid paraffin (e.g., 4 litres) with heating facilities and heated work area, excess paraffin drainage facility, a cold plate area, and possibly a built-in forceps heater.

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 13, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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