AMS Innovative Center San Jose American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San Jose, CA 95134 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San Jose, CA 95134
Brand
AMS Innovative Center San Jose
Lot Codes / Batch Numbers
Part Number: 0010-2090B, Lot Numbers 705 N and 706 E
Products Sold
Part Number: 0010-2090B, Lot Numbers 705 N and 706 E
AMS Innovative Center San Jose is recalling American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. due to Control knob break: The knob used to finely control the direction of the laser energy may break.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Control knob break: The knob used to finely control the direction of the laser energy may break.
Recommended Action
Per FDA guidance
American Medical Systems, Inc. (AMS) issued Important: Medical Device Recall AMS Greenlight ADDStat Fibers notification letters to customers who have purchased the product on June 28, 2007. The customer letter requests recipients that the product use be discontinued, and the fibers be returned. The firm will send replacements.
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