FDA Device recall Z-0144-2014
MLS Torpedo Mini-Light Ophthalmic single-port illumination
- FDA Device
- Class II
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class II recall of MLS Torpedo Mini-Light Ophthalmic single-port illumination by Insight Instruments, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0144-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-27 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Insight Instruments |
| Distribution | US |
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
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.
Identifiers
| code_info | Part Number Lot Number Expiration 11007 M52934 04/2013 11017 M53017…Part Number Lot Number Expiration 11007 M52934 04/2013 11017 M53017 04/2013 11007 M55285 07/2013 11007 M55869 08/2013 11007 M58610 12/2013 11007 M59575 02/2014 11007 M61781 05/2014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0144-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.