Z-1843-2021Class II

Quanta System Sterile Optical Laser Fiber, single use

Name: Z-1843-2021 Quanta System Sterile Optical Laser Fiber, single use
Creator: Quanta System, S.p.A.
Published: 2021-04-27
License: https://open.fda.gov/license/

Quanta System Inc. / initiated 2021-04-27 / Terminated / root cause: manufacturing process

FDA source

Quanta System, S.p.A. began a recall of Quanta System Sterile Optical Laser Fiber, single use on 2021-04-27. FDA classified it as Class II and gives the reason as "Product sterility is potentially compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1843-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-27
Posted: 2021-06-10
Terminated: 2023-09-05
Recalling firm: Quanta System Inc.
Product: Quanta System Sterile Optical Laser Fiber, single use
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Product sterility is potentially compromised.
Root cause tag: manufacturing process
FDA 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 in commerce: 2427 units
Distribution: Nationwide distribution via 6 US distributors
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1843-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1842-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-09
Z-1843-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-09
Z-1844-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-09

Product code GEX

K131473Class II(Quanta System) Surgical Laser FibersQuanta System Spa / cleared 2013-10-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)