FDA Medical Device Recalls (openFDA)
Quanta System, S.p.A.: Quanta System Sterile Optical Laser Fiber, reusable
- Recall number
- Z-1844-2021
- Recalling firm
- Quanta System, S.p.A.
- Product
- Quanta System Sterile Optical Laser Fiber, reusable
- Status
- Terminated
- Initiated
- 2021-04-27
- Posted
- not on file
- Terminated
- 2023-09-05
- Reason
- Product sterility is potentially compromised.
- Root cause
- Process control
- Action
- The recalling firm is sending recall notification letters to its consignees for further dissemination to the user level. Consignees are asked to cease use of impacted product, quarantine impacted goods and dispose of goods in accordance with local regulations. Consignees should complete and return the acknowledgement form.
- Quantity
- 307
- Distribution
- Nationwide distribution via 6 US distributors
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K160513"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 3004378299
- Firm city
- Samarate
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28