Quanta System, S.p.A.: Medical Device Recall in 2021 - (Recall #: Z-1844-2021)

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, reusable

Product Classification:

Class II

Date Initiated: April 27, 2021

Date Posted: June 16, 2021

Recall Number: Z-1844-2021

Event ID: 87814

Reason for Recall:

Product sterility is potentially compromised.

Status: Terminated

Product Quantity: 307

Code Information:

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

Distribution Pattern:

Nationwide distribution via 6 US distributors

Voluntary or Mandated:

Voluntary: Firm initiated