FDA Medical Device Recalls (openFDA)
Quanta System, S.p.A.: Quanta System Sterile Optical Laser Fiber, single use
- Recall number
- Z-1843-2021
- Recalling firm
- Quanta System, S.p.A.
- Product
- Quanta System Sterile Optical Laser Fiber, single use
- 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
- 2427 units
- Distribution
- Nationwide distribution via 6 US distributors
- Lot, serial or model codes
- Product Part Numbers: OAF002011 - lots A194207, A194208, A194528, A194529, A201001, A201002 OAF005511 - lots A184635, A192114, A193613, A194527, A202027 OAF006001 - lots A183626 and A193106 OAF008001 - lot A193616 OAF009901 - lot A192911 and A193108 OAF009911 - lots A192914 and A202028 OAF302711 - lot A202029 OAF402011 - lots A380350, A384633, A392907 OAF702711 - lots A190301, A192113, A192906, A193110, A193111, A193112, A194108, A194211, A194532 OAF703611 - lots A180300, A190302, A190303, A192115, A192908, A193102, A193113, A194209, A194210, A195013, A195014
- 510(k) numbers
- ["K131473"]
- 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