RecallRadar

FDA Device recall Z-1584-2016

Integra 3

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

AgencyFDA Device
Recall numberZ-1584-2016
ClassificationClass II
Statusterminated
Initiated2016-03-11
Published2016-05-04
Last updated2026-09-13 11:54 UTC
CompanyResearch Instruments Site B
DistributionUS

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_infoSerial 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

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.