Z-1584-2016Class II

Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160

Name: Z-1584-2016 Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160
Creator: Research Instruments Ltd - Site B
Published: 2016-03-11
License: https://open.fda.gov/license/

Research Instruments Ltd / initiated 2016-03-11 / Terminated / root cause: design

FDA source

RESEARCH INSTRUMENTS LTD - SITE B began a recall of 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... on 2016-03-11. FDA classified it as Class II and gives the reason as "The units have been fitted with a potentially faulty power supply cable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1584-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-11
Posted: 2016-04-28
Terminated: 2021-03-02
Recalling firm: Research Instruments Ltd
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.
Product code: MQJ Micromanipulators And Microinjectors, Assisted Reproduction
Reason for recall: The units have been fitted with a potentially faulty power supply cable.
Root cause tag: design
FDA root cause: Device Design
Action: Research Instruments sent a recall notification dated 03/11/2016, via UPS with confirmed delivery receipt, to all affected customers. The letter identified the affected product, problem and the action needed to be taken by the customer. The letter asked customers to contact Research Instruments First Line Support if they had any questions.
Quantity in commerce: 380 units
Distribution: Worldwide Distribution - US Nationwide in the states of: MA, NY and countries of : Algeria, Australia, Austria, Bahrain, Belgium, British Virgin Islands, Bulgaria, Canada, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Nigeria, Norway, Pakistan, Peru, Poland, Romania, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UAE, Ukraine, United Kingdom, and Vietnam,
Product codes and lots: Serial numbers: 2-381

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1584-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1584-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-28

Product code MQJ

K003142Class IIMicromanipulatorResearch Instruments , Ltd. / cleared 2000-11-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)