FDA Device recall Z-1584-2016
Integra 3
- FDA Device
- Class II
- terminated
- Published 2016-05-04
On 2016-05-04 the FDA classified a Class II recall of Integra 3 by Research Instruments Site B, citing the units have been fitted with a potentially faulty power supply cable.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1584-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-11 |
| Published | 2016-05-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Research Instruments Site B |
| Distribution | US |
Product
Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 Product Usage: The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a configuration comprising two TDU500 micromanipulators, two air syringes and temperature control system within a single housing.
Reason
The units have been fitted with a potentially faulty power supply cable.
Identifiers
| code_info | Serial numbers: 2-381 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1584-2016%22
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