Synergetics Inc
Synergetics Inc has 4 FDA enforcement events on this register (37 product records) between 2013 and 2024: 4 device; the busiest year was 2013 with 2.
25% of its events are Class I; the most common class is Class II (3). 1 event is listed as ongoing; the recalling firm's address is in MO.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 12 Jun 2024 | BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye) | Device | Class I | 4 | Ongoing |
| 11 Aug 2016 | 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system. | Device | Class II | 4 | Terminated |
| 9 Dec 2013 | Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Packed 6 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Device | Class II | 28 | Terminated |
| 30 Jul 2013 | Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery. | Device | Class II | 1 | Terminated |
By type and class
Class I: 25% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Synergetics Inc had?
4 enforcement events (37 product records) on this register, 2013–2024: 4 device.
Are any Synergetics Inc recalls ongoing?
1 event is listed as ongoing in the current openFDA export.
What class are Synergetics Inc recalls?
3 Class II, 1 Class I. 25% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.