MLS Torpedo Mini-Light Ophthalmic single-port illumination — Class II medical device recall Z-0144-2014
Terminated recall by Insight Instruments, Inc., reported 2013-11-13, distributed nationwide. The product was registered and distributed as a Class I medical device and was subsequently determined to be a
| Recall number | Z-0144-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Insight Instruments, Inc., Stuart, FL, United States |
| Recall initiated | 2013-06-27 |
| Classified | 2013-11-04 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2017-09-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, CZ, DE, ES, NL, TR |
| Quantity | 10,212 |
| Lot numbers | 11007, 11017, M52934, M53017, M55285, M55869, M58610, M59575, M61781 |
| Model numbers | 11007, 11017, M52934, M53017, M55285, M55869, M58610, M59575, M61781MLS |
Product
MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.
Reason for recall
The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.
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-0144-2014. 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.