Recall database

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-1136-2026

Sysmex America, Inc. recalls TS-10/TS-10H Tube Sorter

Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.

Labeled Or Promoted For A Specific Medical Use General Purpose Laboratory Equipment
Software design

Sysmex America, Inc.ILJan 28, 2026

Class IIOngoingZ-2345-2025

Dynex Technologies, Inc. recalls Dynex Agility Sample Tips

The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidentified as a different tip type, rendering it incompatible with…

Labeled Or Promoted For A Specific Medical Use General Purpose Laboratory Equipment
Labeling Change Control

Dynex Technologies, In…VAAug 27, 2025