Synergetics, Inc.
Also registered as SYNERGETICS USA, INC.
United StatesFDA applicant, unverified FDA FEI 1000119053
Synergetics, Inc. is a medical device manufacturer, with 580 devices listed in FDA GUDID and FDA 510(k) (FDA Class I, Class II and Unclassified) and 37 FDA recalls as of 13 Nov 2026.
- Devices
- 580
- Registrations
- FDA
- FDA recalls
- 374 ongoing
Registry facts
- Registries
- FDA GUDID 562
- FDA 510(k) 18
- Device classes
- FDA Class I 340
- FDA Class II 238
- FDA Unclassified 2
- FDA recalls
- Identifiers
- FDA FEI 1000119053
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 580 devicesShowing 1-50 of 580
Company details
- FDA FEI number
- 1000119053
- Address
- 3845 Corporate Centre Dr, O Fallon, MO, 63368
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 4
- 2025 0
- 2026 0
2024
- 12 Jun 2024 Z-2251-2024 Class I Ongoing Sterilization certificates could not be validated by the supplier
- 12 Jun 2024 Z-2252-2024 Class I Ongoing Sterilization certificates could not be validated by the supplier
- 12 Jun 2024 Z-2253-2024 Class I Ongoing Sterilization certificates could not be validated by the supplier
- 12 Jun 2024 Z-2254-2024 Class I Ongoing Sterilization certificates could not be validated by the supplier
2016
- 11 Aug 2016 Z-0119-2017 Class II Terminated Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
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- 11 Aug 2016 Z-0120-2017 Class II Terminated Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
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- 11 Aug 2016 Z-0121-2017 Class II Terminated Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
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- 11 Aug 2016 Z-0122-2017 Class II Terminated Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
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- 11 Aug 2016 Z-0119-2017 Class II Terminated Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
2013
- 9 Dec 2013 Z-0872-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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- 9 Dec 2013 Z-0873-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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- 9 Dec 2013 Z-0872-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Show the 25 most recent of 37 recalls
2013
- 9 Dec 2013 Z-0874-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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- 9 Dec 2013 Z-0875-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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- 9 Dec 2013 Z-0876-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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- 9 Dec 2013 Z-0877-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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- 9 Dec 2013 Z-0878-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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- 9 Dec 2013 Z-0879-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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- 9 Dec 2013 Z-0880-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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- 9 Dec 2013 Z-0881-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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- 9 Dec 2013 Z-0882-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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- 9 Dec 2013 Z-0883-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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- 9 Dec 2013 Z-0884-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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- 9 Dec 2013 Z-0885-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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- 9 Dec 2013 Z-0886-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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- 9 Dec 2013 Z-0887-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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- 9 Dec 2013 Z-0888-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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- 9 Dec 2013 Z-0874-2014 Class II Terminated Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Frequently asked questions
How many devices does Synergetics, Inc. have in the registry?
The registry currently lists 580 devices for Synergetics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Synergetics, Inc.'s devices?
Among its 50 most recently registered devices, Synergetics, Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Synergetics, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Synergetics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Synergetics, Inc.?
FDA recall records list 37 recalls initiated by Synergetics, Inc., the most recent initiated on 12 Jun 2024. 4 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Synergetics, Inc. in the registry?
The most recently registered devices listed for Synergetics, Inc. include Synergetics 12.01, Synergetics 20.51, PHOTON PSPA-P2 and Synergetics 39.27.23.