Genicon GENILook Model 200-105-151 — Class II medical device recall Z-2270-2020
Ongoing recall by Genicon, Inc., reported 2020-06-17, distributed in AL, DE, FL, GA, MO, NC, TN. There is potential for the plastic optical tip to become detached from the metal shaft.
| Recall number | Z-2270-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genicon, Inc., Winter Park, FL, United States |
| Recall initiated | 2018-08-21 |
| Classified | 2020-06-05 |
| Reported by FDA | 2020-06-17 |
| Distributed | AL, DE, FL, GA, MO, NC, TN |
| Countries outside the US | BH, CL, CY, DK, DO, EG, GB, HK, IE, JO, KR, KW, LB, PK, SG, TH, ZA |
| Reason classes | device malfunction |
| Lot numbers | I7718-D, I7780-D, I8068-D |
| Model numbers | 200-105-151, 5MM |
Product
Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
Reason for recall
There is potential for the plastic optical tip to become detached from the metal shaft.
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-2270-2020. 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.