Quanta System, S.p.A recalls

Quanta System, S.p.A has 6 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 16 Jun 2021. The most frequent reason is sterility.

Total recalls6since 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 16 Jun 2021

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 6 100%Class III 0 0%

Why quanta system, s.p.a is recalled

Sterility350%
Other Reasons350%

Product types

Other Medical Devices350%
Heart & Vascular Devices350%

By year

2021350%
2013350%

All quanta system, s.p.a recalls, newest first

6 total

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

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.