The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1584-2016·Announced 2016-05-04

Research Instruments Recalls Integra 3 Micromanipulators Due to Faulty Power Cable

Research Instruments Ltd is recalling 380 Integra 3 micromanipulators because they were fitted with a potentially faulty power supply cable.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potentially faulty power supply cable, which presents a risk of harm (such as electrical shock or fire) even though specific injuries are not reported in the source text.

Plain-English summary

Research Instruments Ltd is recalling 380 units of the Integra 3 micromanipulator, model numbers 6-54-100, 6-54-110, 6-54-150, and 6-54-160. These devices are used to accurately position microtools under a microscope for assisted reproduction techniques. The recall involves serial numbers 2-381.

The recall was initiated because the units have been fitted with a potentially faulty power supply cable. The agency has classified this as a Class II recall. The affected products were distributed worldwide, including in the United States (Massachusetts and New York) and numerous international locations.

Consumers and healthcare facilities should stop using the affected devices and contact Research Instruments Ltd for instructions on how to proceed with the recall.

The recalled product

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…
Manufacturer
RESEARCH INSTRUMENTS LTD - SITE B
Category
Medical Device — Micromanipulator
Hazard
Affected units
380

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial numbers: 2-381

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Related recalls

Same hazard · electrical hazard

See all →

Similar recalls