CLASS II Device recall · Reported 16 Jun 2021 · FDA Enforcement Report

Sterile Optical Laser Fiber, single use recalled by Quanta System, S.p.A

Quanta System, S.p.A is recalling Sterile Optical Laser Fiber, single use, distributed nationwide in the US. The recall was initiated on 27 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct 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

Quantity recalled2427 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1843-2021
FDA event ID: 87814
Recalling firm: Quanta System, S.p.A, Samarate, N/A
Classification: Class II
Status: Terminated
Recall initiated: 27 Apr 2021
FDA classified: 9 Jun 2021
Reported: 16 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

27 Apr 2021	Recall initiated by company
9 Jun 2021	Classified by FDA	+43 days
16 Jun 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product sterility is potentially compromised.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Quanta System Sterile Optical Laser Fiber, single use

Where it was distributed

Nationwide distribution via 6 US distributors

Nationwide

Questions about this recall

Why was it recalled?

Product sterility is potentially compromised.

Which lots are affected?

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

Where was it sold?

Nationwide distribution via 6 US distributors

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 87814

This product is part of a recall event; the main page for the event is Sterile Optical Laser Fiber, reusable recalled by Quanta System, S.p.A.

Reported	Class	Recall	Company	Reason	Where
16 Jun 2021	CLASS II	Sterile Optical Laser Fiber, reusable recalled by Quanta System, S.p.A	Quanta System, S.p.A	Sterility	Nationwide
16 Jun 2021	CLASS II	Olympus Sterile Optical Laser Fiber, single use and reusable recalled	Quanta System, S.p.A	Sterility	Nationwide

More recalls from Quanta System, S.p.A

All 6

Reported	Class	Recall	Company	Reason	Where
16 Jun 2021Device	CLASS II	Olympus Sterile Optical Laser Fiber, single use and reusable recalled	Quanta System, S.p.A	Sterility	Nationwide
16 Jun 2021Device	CLASS II	Sterile Optical Laser Fiber, reusable recalled by Quanta System, S.p.A	Quanta System, S.p.A	Sterility	Nationwide
23 Jan 2013Device	CLASS II	Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm recalled	Quanta System, S.p.A	Other	4 states
23 Jan 2013Device	CLASS II	Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser recalled	Quanta System, S.p.A	Other	4 states
23 Jan 2013Device	CLASS II	Eterna Giovinezza System, Powered Laser Surgical Instrument recalled	Quanta System, S.p.A	Other	4 states

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