Neomedix Corp NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator
Brand
Neomedix Corp
Lot Codes / Batch Numbers
Model Number 550014, Lot Number 061205-1, Serial Numbers: 10117, 10119, 10120, 10122, 10124, 100129, and 10133.
Products Sold
Model Number 550014; Lot Number 061205-1; Serial Numbers: 10117, 10119, 10120, 10122, 10124, 100129, and 10133.
Neomedix Corp is recalling NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator due to Failure of irrigation flow: The pinch valve in a few pumps may not consistently open to allow irrigation flow. In over 450 surgeries, the firm confi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failure of irrigation flow: The pinch valve in a few pumps may not consistently open to allow irrigation flow. In over 450 surgeries, the firm confirmed one instance of a valve that did not open. The electrically activated pinch valve in the NeoMedix Trabectome I/A pump activates irrigation flow to the eye during Trabectome surgery.
Recommended Action
Per FDA guidance
On May 31, 2007 NeoMedix mailed a Customer letter to all consignees informing them of the hazard. The letter also indicated to the customers they NeoMedix has developed a minor modification/upgrade that is designed to assure that the pinch valve opens at the appropriate time. The customers were instructed this modification requires return of their existing pump for modification and testing at the firm's facility before its return. In the event that surgeries have already been scheduled, NeoMedix will provide a loaner unit until the suspect unit can be modified and returned to you. The letter also indicated the cost of the modification and/or use of a loaner unit will be entirely at NeoMedix expense. You will be contacted to establish the details of implementing this modification.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026