Quanta System, S.p.A.: Medical Device Recall in 2021 - (Recall #: Z-1843-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Quanta System Sterile Optical Laser Fiber, single use

Product Classification:

Class II

Date Initiated: April 27, 2021

Date Posted: June 16, 2021

Recall Number: Z-1843-2021

Event ID: 87814

Reason for Recall:

Product sterility is potentially compromised.

Status: Terminated

Product Quantity: 2427 units

Code Information:

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

Distribution Pattern:

Nationwide distribution via 6 US distributors

Voluntary or Mandated:

Voluntary: Firm initiated