Synergetics Recalls 25 Gauge VersaVit 2.0 Vitrectomy Cutters
Synergetics Inc is recalling 25 gauge VersaVit 2.0 Vitrectomy Cutters because they may not operate within the correct pressure pulse specifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Synergetics Inc is recalling 9 units of the 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935. The devices are packaged in a Tyvek/Mylar double pouch configuration. The recall involves Lot number M546500 with an expiration date of 10/2018.
The recall was initiated because the vitrectomy cutters were found not to be operating within the correct pressure pulse per specification. This defect may affect the performance of the surgical instrument during use.
The affected devices were distributed to Kentucky, Virginia, Tennessee, Ohio, Indiana, California, New Jersey, New York, Texas, South Carolina, Alabama, Mississippi, Michigan, and Utah. Foreign distribution included the United Kingdom, France, Mexico, and India. Users should stop using the affected devices and contact Synergetics Inc for further instructions.
The recalled product
- Product
- 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
- Manufacturer
- Synergetics Inc
- Hazard
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot number M546500 (1 each or box of 6 each)
- exp 10/2018
Distribution
Part of a larger recall action
This product is one of 4 recalled by Synergetics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Synergetics Inc
See all →- SevereIntravitreal Injection Kit Recalled for Unvalidated Sterilization Certificates
FDA (Devices) · 2024-07-17
- SevereBausch+Lomb I-PACK Injection Kit Recalled for Unvalidated Sterilization
FDA (Devices) · 2024-07-17
- CriticalMedical Device Recall: Bausch+Lomb Intravitreal Injection Kit Unvalidated Sterilization
FDA (Devices) · 2024-07-17
- SevereBAUSCH+LOMB I-PACK Injection Kit Recalled Due to Sterilization Validation Failure
FDA (Devices) · 2024-07-17
- HighSynergetics VersaVit 2.0 Procedure Packs Recalled for Pressure Defect
FDA (Devices) · 2016-10-26
Same hazard · malfunction
See all →- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- ModerateOlympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults
FDA (Devices) · 2026-07-29
- High
- ModeratePhilips Azurion 3M15 Medical Imaging Systems Recalled Due to Software Issue
FDA (Devices) · 2026-06-10
- SevereElectric Start Pressure Washers Recalled for Carbon Monoxide Hazard
CPSC · 2026-05-14