Stryker Corporation: Insufflator, Hysteroscopic
Stryker Corporation is recalling Thermedx FluidSmart Urology Tube Sets (model REF LL0006) that were distributed nationwide because some units did not meet quality standards. These tube sets are used with fluid management systems during surgical procedures in gynecology, urology, and orthopedic surgery to manage irrigation fluid and measure fluid levels. The recall affects medical facilities across the United States that received affected products.
- Recalling firm
- Stryker Corporation
- Product
- Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.
- Reason
- Due to nonconforming products being inadvertently distributed.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-09
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide distribution in the state of GA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/acdda4c2-193b-48e2-8703-4e9372ca9baf