Reported Jun 16, 2021 · Terminated

Quanta System Sterile Optical Laser Fiber, single use

Quanta System, S.p.A.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Quanta System, S.p.A. · Via Acquedotto 109 · Samarate, N/A · N/A

Is this the product you have?

  • Quanta System Sterile Optical Laser Fiber, single use
Lot codes and dates

3 of 3 products

Products covered by this recall
#Product as published
1lot A193616 OAF009901
2lot A192911 and A193108 OAF009911 - lots A192914 and A202028 OAF302711
3lot 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
Amount recalled
2427 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

Product sterility is potentially compromised.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 5, 2023 · Data as of Sep 19, 7:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.