Integra 3 — Class II medical device recall Z-1584-2016
Terminated recall by RESEARCH INSTRUMENTS LTD - SITE B, reported 2016-05-04, distributed nationwide. The units have been fitted with a potentially faulty power supply cable.
| Recall number | Z-1584-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RESEARCH INSTRUMENTS LTD - SITE B, Falmouth, N/A, United Kingdom |
| Recall initiated | 2016-03-11 |
| Classified | 2016-04-28 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2021-03-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BH, CA, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, HK, IE, IL, IN, IQ, IR, IT, JO, JP, KR, KW, LK, LT, MT, MX, MY, NG, NO, PE, PK, PL, RO, RS, SE, SG, SK, TH, TN, TR, TW, UA, VN, ZA |
| Quantity | 380 units |
| Serial numbers | 2-381 |
| Model numbers | 6-54-100, 6-54-110, 6-54-150, 6-54-160 |
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 for recall
The units have been fitted with a potentially faulty power supply cable.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1584-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.