FDA Device recall Z-2163-2015
365¿M Lithotripsy Fiber- Reusable
- FDA Device
- Class II
- terminated
- Published 2015-07-29
On 2015-07-29 the FDA classified a Class II recall of 365¿M Lithotripsy Fiber- Reusable by American Medical Systems Innovation Center Silicon Valley, citing validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusabl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2163-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-28 |
| Published | 2015-07-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | American Medical Systems Innovation Center Silicon Valley |
| Distribution | US |
Product
365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).
Reason
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products
Identifiers
| code_info | Model 8013056; All product manufactured from April 8, 2012 to April 8, 2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2163-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.