FDA Device recall Z-1844-2021
Quanta System Sterile Optical Laser Fiber, reusable
- FDA Device
- Class II
- terminated
- Published 2021-06-16
On 2021-06-16 the FDA classified a Class II recall of Quanta System Sterile Optical Laser Fiber, reusable by Quanta System S P A, citing product sterility is potentially compromised.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1844-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-27 |
| Published | 2021-06-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Quanta System S P A |
| Distribution | US |
Product
Quanta System Sterile Optical Laser Fiber, reusable
Reason
Product sterility is potentially compromised.
Identifiers
| code_info | Product Part Numbers: OAF002013 Lots A201003 OAF005513 Lots A184636, A192118, A193101 OAF006003 Lot A195008…Product Part Numbers: OAF002013 Lots A201003 OAF005513 Lots A184636, A192118, A193101 OAF006003 Lot A195008 OAF008003 Lots A193615, A194021 OAF008013 Lots A183623, A192119 OAF009903 Lots A193109, A193617 OAF009913 Lots A181350, A192910 OAF702713 Lots A182415, A193104, A194109, A194723 OAF703613 Lot A180150 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1844-2021%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.